全面解析生物药的研发与申报流程
<div style="max-width:677px;overflow:hidden;"><p style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);widows: 1;text-align: center;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;font-size: 18px;color: rgb(0, 75, 189);letter-spacing: 1px;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;">生物药物的研究开发流程</strong></p><section data-role="title" data-tools="135编辑器" data-id="110560" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="margin: 10px auto;outline: 0px;max-width: 100%;text-align: center;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="outline: 0px;max-width: 100%;display: flex;justify-content: center;align-items: center;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="outline: 0px;max-width: 100%;width: 60px;line-height: 0;flex-shrink: 0;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><svg version="1.1" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" x="0px" y="0px" viewBox="0 0 94.71 22.73" style="visibility: visible;"><g style="visibility: visible;"><rect x="14.71" y="21.73" transform="matrix(-1 5.493327e-11 -5.493327e-11 -1 109.4256 44.4508)" style="fill: rgb(114, 193, 244);visibility: visible;" width="80" height="1"></rect><polygon style="fill: rgb(114, 193, 244);visibility: visible;" points="17.44,6.32 21.2,6.32 15.72,22.73 11.97,22.73 "></polygon><polygon style="fill: rgb(0, 112, 192);visibility: visible;" points="7.52,0 13.16,0 5.64,22.73 0,22.73 "></polygon></g></svg></section></section></section></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="margin-top: 15px;margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;">新药研究是一项综合性的探索工作，是一项创造性的科学研究，必须多学科相互配合。发现有效化合物是研究新药的基础，开发新药的物质来源可以是天然资源或生物合成或化学合成的化合物。先导化合物的发现是研究新药的起始。在研究其结构和性质后，通过生物系统的各项试验，了解化合物的药效、毒性、药代以及与机体的相互作用，再进一步进行构效关系研究和结构的化、改造、修饰或优化，从而发现并创造具有新型结构与特殊药理作用的新药。</span></p><p style="margin-top: 15px;margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;">生物药物的研究开发过程一般有以下三个阶段。</span></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p></section><section data-role="title" data-tools="135编辑器" data-id="110562" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="margin: 10px auto;outline: 0px;max-width: 100%;text-align: left;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section hm_fix="260:347" style="outline: 0px;max-width: 100%;display: flex;justify-content: flex-start;align-items: flex-end;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="margin-right: 8px;outline: 0px;max-width: 100%;font-size: 28px;color: rgb(0, 112, 192);font-style: italic;line-height: 22px;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;">0</strong><strong data-original-title="" title="" style="outline: 0px;max-width: 100%;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;">1</strong></section><section style="outline: 0px;max-width: 100%;width: 60px;line-height: 0;flex-shrink: 0;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><svg version="1.1" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" x="0px" y="0px" viewBox="0 0 94.71 22.73" style="visibility: visible;"><g style="visibility: visible;"><rect x="14.71" y="21.73" transform="matrix(-1 5.493327e-11 -5.493327e-11 -1 109.4256 44.4508)" style="fill: rgb(114, 193, 244);visibility: visible;" width="80" height="1"></rect><polygon style="fill: rgb(114, 193, 244);visibility: visible;" points="17.44,6.32 21.2,6.32 15.72,22.73 11.97,22.73 "></polygon><polygon style="fill: rgb(0, 112, 192);visibility: visible;" points="7.52,0 13.16,0 5.64,22.73 0,22.73 "></polygon></g></svg></section></section><section style="margin-top: 6px;outline: 0px;max-width: 100%;font-size: 16px;letter-spacing: 1px;color: rgb(0, 75, 189);font-style: italic;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong data-brushtype="text" style="outline: 0px;max-width: 100%;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;">制订研究计划和制备新化合物阶段</strong></section></section></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="margin-top: 15px;margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;">这一阶段是</span><strong style="outline: 0px;max-width: 100%;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;">调查研究，收集资料，整理文献，制定计划进行实验和制备供筛选化合物（<span style="max-width: 100%;max-inline-size: 100%;cursor: text;color: rgb(0, 0, 0);caret-color: rgb(255, 0, 0);visibility: visible;outline: none 0px !important;box-sizing: border-box !important;overflow-wrap: break-word !important;">生物药物供筛选的化合</span><span style="max-width: 100%;max-inline-size: 100%;cursor: text;color: rgb(0, 0, 0);caret-color: rgb(255, 0, 0);visibility: visible;outline: none 0px !important;box-sizing: border-box !important;overflow-wrap: break-word !important;"></span><span style="max-width: 100%;max-inline-size: 100%;cursor: text;color: rgb(0, 0, 0);caret-color: rgb(255, 0, 0);visibility: visible;outline: none 0px !important;box-sizing: border-box !important;overflow-wrap: break-word !important;">物包括从天然资源获得的化合物和以生物技术手段获得的化合物</span>）</span></strong><span style="outline: 0px;max-width: 100%;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;">。此阶段研究主要是为筛选和进行实验室研究提供物质基础。</span></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p></section><section data-role="title" data-tools="135编辑器" data-id="110562" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="margin: 10px auto;outline: 0px;max-width: 100%;text-align: left;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section hm_fix="260:347" style="outline: 0px;max-width: 100%;display: flex;justify-content: flex-start;align-items: flex-end;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="margin-right: 8px;outline: 0px;max-width: 100%;font-size: 28px;color: rgb(0, 112, 192);font-style: italic;line-height: 22px;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;">0</strong><strong data-original-title="" title="" style="outline: 0px;max-width: 100%;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;">2</strong></section><section style="outline: 0px;max-width: 100%;width: 60px;line-height: 0;flex-shrink: 0;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><svg version="1.1" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" x="0px" y="0px" viewBox="0 0 94.71 22.73" style="visibility: visible;"><g style="visibility: visible;"><rect x="14.71" y="21.73" transform="matrix(-1 5.493327e-11 -5.493327e-11 -1 109.4256 44.4508)" style="fill: rgb(114, 193, 244);visibility: visible;" width="80" height="1"></rect><polygon style="fill: rgb(114, 193, 244);visibility: visible;" points="17.44,6.32 21.2,6.32 15.72,22.73 11.97,22.73 "></polygon><polygon style="fill: rgb(0, 112, 192);visibility: visible;" points="7.52,0 13.16,0 5.64,22.73 0,22.73 "></polygon></g></svg></section></section><section style="margin-top: 6px;outline: 0px;max-width: 100%;font-size: 16px;letter-spacing: 1px;color: rgb(0, 75, 189);font-style: italic;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong data-brushtype="text" style="outline: 0px;max-width: 100%;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;">筛选和临床前研究阶段</strong></section></section></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="margin-top: 15px;margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-size: 15px;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-family: 微软雅黑, Microsoft YaHei;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;">首先进行药效学的药理筛选，通常用实验动物模型进行筛选，也可以通过药效学靶标进行分子水平或细胞水平筛选，然后再用动物模型进行体内筛选，筛选时应尽量缩短动物模型和临床病理作用之间的差距。生物新药的临床前研究主要包括实验研究，小量试制和中间试制三个阶段。</span></span></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(0, 75, 189);visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;visibility: visible;box-sizing: border-box !important;overflow-wrap: break-word !important;">1、实验研究阶段</span></strong></span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">实验研究是基础性研究，研究内容主要有生产用菌、毒种和细胞株的构建、培养、遗传稳定性和生物组织选择，有效成分的提取，纯化及其理化特性、结构与生物特征的分析等研究，取得制造和质量检定的基本条件条件和方法。</span></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(0, 75, 189);box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">2、小量试验阶段</span></strong></span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">根据实验研究结果，确定配方及给药方式，建立制备工艺和检定方法，实验小批量样品进行临床前初步安全性和有效性的实验（包括药效作用及其特点、毒理及初步药代试验），并制定制造与检定基本要求。确定目的化合物具有新药的可能性。</span></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(0, 75, 189);box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">3、中间试制阶段</span></strong></span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">（1）生产工艺基本定型，产品质量和产率相对稳定，并能放大生产。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">（2）有产品质量标准、检定方法和保存稳定性资料，并有测定效价的参考品或对照品。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">（3）全面、系统地完成临床前研究工作。括断药的药物化学研究，药理学研究(主要药效学研究，一般药理学研究，药物代谢动力学研究），毒理学研究，以及生物等效性、生物利用度研究和耐受性、依赖性试验等。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">（4）提供自检和中国药品生物制品检定所复检报告及能满足临床试验研究用量的连续三批产品。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">（5）制定较完善的制造检定试行规程和产品使用说明书(草案)。在新药临床前研究项目中，最重要的是新药的安全性及其有效性是否优于已知药物，因此取得临床试验批件的最重要资料是满意的药理学学和毒理学研究结果。</span></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p></section><section data-role="title" data-tools="135编辑器" data-id="110562" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="margin: 10px auto;outline: 0px;max-width: 100%;text-align: left;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section hm_fix="260:347" style="outline: 0px;max-width: 100%;display: flex;justify-content: flex-start;align-items: flex-end;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="margin-right: 8px;outline: 0px;max-width: 100%;font-size: 28px;color: rgb(0, 112, 192);font-style: italic;line-height: 22px;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">0</strong><strong data-original-title="" title="" style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">3</strong></section><section style="outline: 0px;max-width: 100%;width: 60px;line-height: 0;flex-shrink: 0;box-sizing: border-box !important;overflow-wrap: break-word !important;"><svg version="1.1" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" x="0px" y="0px" viewBox="0 0 94.71 22.73"><g><rect x="14.71" y="21.73" transform="matrix(-1 5.493327e-11 -5.493327e-11 -1 109.4256 44.4508)" style="fill:#72c1f4;" width="80" height="1"></rect><polygon style="fill:#72c1f4;" points="17.44,6.32 21.2,6.32 15.72,22.73 11.97,22.73 "></polygon><polygon style="fill:#0070c0;" points="7.52,0 13.16,0 5.64,22.73 0,22.73 "></polygon></g></svg></section></section><section style="margin-top: 6px;outline: 0px;max-width: 100%;font-size: 16px;letter-spacing: 1px;color: rgb(0, 75, 189);font-style: italic;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong data-brushtype="text" style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">临床试验研究阶段</strong></section></section></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="margin-top: 15px;margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-size: 15px;color: rgb(12, 12, 12);box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">新药临床试验是指</span><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">对其临床疗效和安全性作出评价，通过各期临床试验，对新药作出能否上市的结论</span></strong><span style="outline: 0px;max-width: 100%;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">。所以</span><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">临床试验是新药评价的关键阶段，是对新药实际应用价值的最终验证</span></strong><span style="outline: 0px;max-width: 100%;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">。</span></span></p><p style="margin-top: 15px;margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;color: rgb(12, 12, 12);font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">药物的临床试验(包括生物等效性试验)，必须经过CFDA批准；必须执行《药物临床试验质量管理规范》(GCP)。申请新药注册，应当进行临床试验。</span><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;color: rgb(12, 12, 12);font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">临床试验分为Ⅰ、Ⅱ、 Ⅲ、Ⅵ期。新药在批准上市前，应当进行Ⅰ、Ⅱ、Ⅲ期临床试验。经批准后，个别情况下可仅进行Ⅱ期和Ⅲ期临床试验或者仅进行Ⅲ期临床试验。</span></strong></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(0, 75, 189);box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">1、Ⅰ期临床试验</span></strong></span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">初步的临床药理学及人体安全性评价试验。观察人体对于新药的耐受程度和药代动力学，为制定给药方案提供依据。</span></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(0, 75, 189);box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">2、Ⅱ期临床试验</span></strong></span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">治疗作用初步评价阶段。</span><span style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">其目的是初步评价药物对目标适应</span>症<span style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">患者的治疗作用和安全性，也包括为设计Ⅲ期临床试验研究和确定给药剂量的方案提供依据。</span><span style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">此阶段的研究设计可以根据具体的研究目的，采用多种形式，包括随机双盲法对照临床试验。</span></span></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(0, 75, 189);box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">3、Ⅲ期临床试验</span></strong></span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">治疗作用确证阶段。其目的是进一步验证药物对目标适应证患者的治疗作用和安全性，评价其利益与风险关系，最终为药物注册申请的上市提供充分的依据。试验一般应采用具有足够样本量的随机双盲法对照试验。</span></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(0, 75, 189);box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">4、Ⅵ期临床试验</span></strong></span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">新药上市后由申请人进行的应用研究阶段。其目的是考察在广泛使用条件下药物的疗效和不良反应、评价在普通或者特殊人群中使用的利益与风险关系以及改进给药剂量等。</span></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="margin-top: 15px;margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">新生物药物的种类繁多，如天然生物药物、 反义药物新型疫苗、治疗性抗体、基因工程药物、基因治疗药物等。药物种类不同，新药申报和审批程序大同小异、但这些药物的研究过程是不同的。现仅以基因工程药物为例来说明它的研究过程。</span></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="margin-top: 15px;margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">(1)实验室研究阶段</span></strong><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;"> 基因工程药物是生物药物的重要组成部分，研究开发个新的基因工程药物，并把研究成果推向产业化生产，这中间有很多步骤和技术环节。</span></p><p style="margin-top: 15px;margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">首先选择有药用价值的蛋白质,也称“目的蛋白”，研究该蛋白的结构、功能、性质和作用。</span></p><p style="margin-top: 15px;margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">其次，构建具有目的基因的高效表达的工程细胞。目的基因的来源有全合成法、以mRNA为模板的RTFCR法、以eDNA文库为模板的PCR法等。一般大目的基因可从总RNA文库中分离出总mRNA，利用亲和层析分离出目标蛋白的mRNA，并经反转录获得cDNA或从cDNA文库通过PCR扩增所需的eDNA,测eDNA序列以确定为目的DNA；选择一种合适的宿主细胞系统(细菌、酵母、动物细胞等)和合适的载体；重组(构建)高效表达载体，并转染人宿主细胞；筛选阳性克隆，获得工程细胞或工程菌株，测定该工程细胞或工程菌株的稳定性(传代50 ~ 100代)和载体结构稳定性以及表达产率的稳定性(SDS-PAGE); 符合预定目标后，建立生产种子细胞库，为了保证种子细胞库的稳定性，要建立两级种子库，包括主细胞库和生产细胞库，要保证建细胞库时细胞的均一性。</span></p><p style="margin-top: 15px;margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">建立生产细胞库后， 要在实验室规模的条件下，研究细胞培养和发酵最佳方案。初步建立目标蛋白的高效分离、纯化和制剂方案。这两个方案确定后，写出工艺规程。参照有关基因工程药物质量标准，建立目标蛋白质量控制方法和标准。在得到少量的纯目的蛋白后，初步进行药物体内、外疗效试验，基本明确目的蛋白疗效后，再进行以下研究。</span></p><p style="margin-top: 15px;margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">(2)中试研究阶段</span></strong><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;"> 这一阶段的主要任务是把实验室研究成果扩大成中试规模的产业化生产。将实验室规模扩大成中试生产，所采用的工艺路线基本与实验室工艺规程致， 要最大可能地提高目标蛋白的得率及保证蛋白的纯度和活性，并能有效的去除核酸、内毒素及其他有害杂质。要有工艺路线优化记录；对发酵培养、粗提、纯化各步的体积、蛋白量、浓度、纯度、活性及比活性、回收率等均应记录;要有中间产品质量控制要求等。</span></p><p style="margin-top: 15px;margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">中试规模连续生产三批产品，要求工艺稳定，质量稳定，有工艺规程和质量控制标准。三批产品的总量要达到:自检和中检所全部检用量，加上临床前动物试验全部用量和I、I期临床试验用量。</span></p><p style="margin-top: 15px;margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">如果临床剂量大、疗程长，需要产品的量就大，要</span>根<span style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">据不同产品来确定中试规模。</span><span style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">同时必须在CFDA认证过的GMP厂房内生产。</span><span style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">对于目的蛋白制剂的研究在新药研究与开发中也占有重要的地位，要提供处方依据；</span><span style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">进行主药与辅料相互作用研究；</span><span style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">要依据《中国药典》制剂通则的要求进行制剂稳定性试验研究等。</span></span></p><p style="margin-top: 15px;margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">(3)临床前动物试验阶段</span></strong><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;"> 药物临床前研究应当执行有关管理规定，其中安全性评价研究必须执行《药物非临床研究质量管理规范》(GLP)。从事药物研究开发的机构必须具有与试验研究项目相适应的人员，场地设备、仪器和管理制度:所用试验动物、试剂和原材料应当符合国家有关规定和要求，并应当保证所有试验数据和资料的真实性。</span></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="margin-top: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;color: rgb(12, 12, 12);font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">临床前所有动物试验最好在SFDA包认证的GLP实验室进行，包括：</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(12, 12, 12);font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">①体内、体外药效试验；</span></strong></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(12, 12, 12);font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">②一般药理试验；</span></strong></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(12, 12, 12);font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">③过板试验；</span></strong></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(12, 12, 12);font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">④急性毒性试验；</span></strong></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(12, 12, 12);font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑤长期毒性试验；</span></strong></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(12, 12, 12);font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑥药代动力学试验；</span></strong></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(12, 12, 12);font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑦三致试验(致癌、致畸、致突变)。</span></strong></p><p style="margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;color: rgb(12, 12, 12);font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">这些试验的目的是对中试产品进行综合性评价，并初步确定产品的临床试验方案。</span></p><p style="margin-bottom: 0em;outline: 0px;max-width: 100%;text-align: center;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br></p><p style="margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word 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inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p></section><section data-role="title" data-tools="135编辑器" data-id="110562" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="margin: 10px auto;outline: 0px;max-width: 100%;text-align: left;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section hm_fix="260:347" style="outline: 0px;max-width: 100%;display: flex;justify-content: flex-start;align-items: flex-end;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="margin-right: 8px;outline: 0px;max-width: 100%;font-size: 28px;color: rgb(0, 112, 192);font-style: italic;line-height: 22px;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">0</strong><strong data-original-title="" title="" style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">1</strong></section><section style="outline: 0px;max-width: 100%;width: 60px;line-height: 0;flex-shrink: 0;box-sizing: border-box !important;overflow-wrap: break-word !important;"><svg version="1.1" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" x="0px" y="0px" viewBox="0 0 94.71 22.73"><g><rect x="14.71" y="21.73" transform="matrix(-1 5.493327e-11 -5.493327e-11 -1 109.4256 44.4508)" style="fill:#72c1f4;" width="80" height="1"></rect><polygon style="fill:#72c1f4;" points="17.44,6.32 21.2,6.32 15.72,22.73 11.97,22.73 "></polygon><polygon style="fill:#0070c0;" points="7.52,0 13.16,0 5.64,22.73 0,22.73 "></polygon></g></svg></section></section><section style="margin-top: 6px;outline: 0px;max-width: 100%;font-size: 16px;letter-spacing: 1px;color: rgb(0, 75, 189);font-style: italic;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong data-brushtype="text" style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">生物药物新药申请和生物制品的分类</strong></section></section></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">新药申请是指未曾在中国境内上市销售的药品的注册申请。</span><span style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">已上市药品改变剂型、改变给药途径、增加新适应</span>症<span style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">的，也按照新药申请管理。</span></span></strong><span style="outline: 0px;max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">已有国家标准的药品申请，是指生产CFDA已经颁布正式标准的药品的注册申请，此类新药申请，按照已有国家标准药品申请的程序和要求办理。</span></span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">药品注册申请人(以下简称申请人)，是指提出药品注册申请，承担相应法律责任、并在该申请获得批准后持有药品批准证明文件的机构。申请药品注册，申请人应当向所在地省、自治区、直辖市(食品)药品监督管理部门提出。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">两个以上单位共同作为新药申请人的，应当向其中药品生产企业所在地省、自治区、直辖市(食品)药品监督管理部门提出申请；申请人均为药品生产企业的，应当向申请生产制剂的药品生产企业所在地省、自治区、直辖市(食品)药品监督管理部门提出申请;申请人均不是药品生产企业的，应当向样品试制现场所在地省、自治区、直辖市( 食品)药品监督管理部门提出申请。</span></span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">单独申请注册药物制剂的，研究用原料药必须具有药品批准文号、(进口药品注册证》或者《医药产品注册证》，该原料药必须通过合法的途径获得。研究用原料药不具有药品批准文号、《进口药品注册证》或者《医药产品注册证》的，必须经CFDA批准。</span></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="margin-top: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">治疗用生物制品分类如下：</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">(1)未在国内外上市销售的生物制品；</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">(2)单克隆抗体；</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">(3)基因治疗、体细胞治疗及其制品；</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">(4)变态反应原制品；</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">(5)由人的、动物的组织或者体液提取的，或者通过发酵制备的具有生物活性的多组分制品；</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">(6) 由</span>已<span style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">上市销售生物制品组成新的复方制品；</span></span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">(7) 已在国外上市销售但尚未在国内上市销售的生物制品；</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">(8)含未经批准菌种制备的微生物制品；</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">(9)与已上市销售制品结构不完全相同且国内外均未上市销售的制品；</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">(10)与已上市销售制品制备方法不同的制品( 例如采用不同表达体系，宿主细胞等)；</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">(11) 首次采用DNA重组技术制备的制品(例如以重组技术替代合成技术。生物组织提取或者发酵技术等)；</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">(12)国内外尚来上市销售的由非注射途径改为注射途径给药，或者由局部用药改为全身给药的制品；</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">(13)改变已上市销售制品的剂型但不改变给药途径的生物制品；</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">(14) 改变给药途径的生物制品(不包括上述12项)；</span></p><p style="margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">(15) 已有国家药品标准的生物制品。</span></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p></section><section data-role="title" data-tools="135编辑器" data-id="110562" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="margin: 10px auto;outline: 0px;max-width: 100%;text-align: left;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section hm_fix="260:347" style="outline: 0px;max-width: 100%;display: flex;justify-content: flex-start;align-items: flex-end;box-sizing: border-box !important;overflow-wrap: break-word !important;"><section style="margin-right: 8px;outline: 0px;max-width: 100%;font-size: 28px;color: rgb(0, 112, 192);font-style: italic;line-height: 22px;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">0</strong><strong data-original-title="" title="" style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">2</strong></section><section style="outline: 0px;max-width: 100%;width: 60px;line-height: 0;flex-shrink: 0;box-sizing: border-box !important;overflow-wrap: break-word !important;"><svg version="1.1" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" x="0px" y="0px" viewBox="0 0 94.71 22.73"><g><rect x="14.71" y="21.73" transform="matrix(-1 5.493327e-11 -5.493327e-11 -1 109.4256 44.4508)" style="fill:#72c1f4;" width="80" height="1"></rect><polygon style="fill:#72c1f4;" points="17.44,6.32 21.2,6.32 15.72,22.73 11.97,22.73 "></polygon><polygon style="fill:#0070c0;" points="7.52,0 13.16,0 5.64,22.73 0,22.73 "></polygon></g></svg></section></section><section style="margin-top: 6px;outline: 0px;max-width: 100%;font-size: 16px;letter-spacing: 1px;color: rgb(0, 75, 189);font-style: italic;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong data-brushtype="text" style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;">新药注册申请应报送的资料</strong></section></section></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="margin-top: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(0, 75, 189);box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">1、综述资料</span></strong></span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">① 药品名称。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">② 证明性文件。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">③ 立题目的与依据。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">④ 研究结果总结及评价。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑤ 药品说明书样稿、起草说明及参考文献。</span></p><p style="margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑥ 包装、标签设计样稿。</span></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="margin-top: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(0, 75, 189);box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">2、药学研究资料</span></strong></span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">① 药学研究资料综述。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">② 生产用原材料研究资料：</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">生产用动物、生物组织或细胞、原料血浆的来源、收集及质量控制等研究资料；</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">生产用细胞的来源、构建(或筛选)过程及鉴定等研究资料；</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">种子库的建立、检定、保存及传代稳定性资料；</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">生产用其他原材料的来源及质量标准。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">③ 原液或原料生产工艺的研究资料，确定的理论和实验依据及验证资料。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">④ 制剂处方及工艺的研究资料,辅料的来源和质量标准，及有关文献资料。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑤ 质量研究资料及有关文献，包括参考品或者对照品的制备及标定，以及与国内外已上市销售的同类产品比较的资料。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑥ 临床试验申请用样品的制造和检定记录。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑦ 制造和检定规程草案，附起草说明及检定方法验证资料。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑧ 初步稳定性研究资料。</span></p><p style="margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑨ 直接接触制品的包装材料和容器的选择依据及质量标准。</span></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="margin-top: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(0, 75, 189);box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">3、药理毒理研究资料</span></strong></span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">① 药理毒理研究资料综述。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">② 主要药效学试验资料及文献资料。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">③ 一般药理研究的试验资料及文献资料。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">④ 急性毒性试验资料及文献资料。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑤ 长期毒性试验资料及文献资料。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑥ 动物药代动力学试验资料及文献资料。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑦ 致突变试验资料及文献资料。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑧ 生殖毒性试验资料及文献资料。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑨ 致癌试验资料及文献资料。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑩ 免疫毒性和(或)免疫原性研究资料及文献资料。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑪ 溶血性和局部(血管、皮肤、黏膜、肌肉等)刺激性等主要与局部、全身给药相关的特殊安全性试验研究和文献资料。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑫ 复方制剂中多种组分药效、毒性、药代动力学相互影响的试验资料及文献资料。</span></p><p style="margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑬ 依赖性试验资料及文献资料。</span></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(0, 75, 189);box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">4、临床试验资料</span></strong></span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">① 国内外相关的临床试验资料综述。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">② 临床试验计划及研究方案草案。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">③ 知情同意书草案。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">④ 临床研究者手册及伦理委员会批准文件。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑤ 临床试验报告。</span></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="margin-top: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(0, 75, 189);box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">5、其他相关资料</span></strong></span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">① 临床前研究工作简要总结。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">② 临床试验期间进行的有关改进L艺、完善质量标准和药理毒理研究等方面的工作总结及试验研究资料。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">③ 对审定的制造和检定规程的修改内容及修改依据。</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">④ 稳定性试验研究资料。</span></p><p style="margin-bottom: 15px;outline: 0px;max-width: 100%;vertical-align: inherit;line-height: 2em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 15px;font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">⑤ 连续3批试产品制造及检定记录。</span></p></section><section data-role="paragraph" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p></section><section data-role="paragraph" style="margin-bottom: 0em;outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;font-size: 13px;color: rgb(89, 89, 89);font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">References：</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 13px;color: rgb(89, 89, 89);font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">《药品质量生产管理规范》2010修订版</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 13px;color: rgb(89, 89, 89);font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">《生物制</span><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 13px;color: rgb(89, 89, 89);font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">药工艺学》</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 13px;color: rgb(89, 89, 89);font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">《生物制药工艺设计》</span></p><p style="outline: 0px;max-width: 100%;vertical-align: inherit;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;caret-color: red;font-size: 13px;color: rgb(89, 89, 89);font-family: 微软雅黑, Microsoft YaHei;box-sizing: border-box !important;overflow-wrap: break-word !important;">《新药注册申报材料》</span></p></section><p style="margin-bottom: 0em;outline: 0px;max-width: 100%;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);color: rgb(53, 53, 53);font-family: Helvetica Neue, Hiragino Sans GB, Microsoft YaHei, 黑体, Arial, sans-serif;font-size: 14px;text-align: center;box-sizing: border-box !important;overflow-wrap: break-word !important;"><br style="outline: 0px;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;"></p><section style="margin-right: 16px;margin-left: 16px;outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;font-size: 16px;background-color: rgb(255, 255, 255);line-height: 1.75em;box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;letter-spacing: 1px;font-size: 13px;color: rgb(178, 178, 178);box-sizing: border-box !important;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(0, 0, 0);font-family: Calibri;font-size: 15px;text-align: left;box-sizing: border-box !important;overflow-wrap: break-word !important;">声明：</span><span style="outline: 0px;max-width: 100%;color: rgb(0, 0, 0);font-family: Calibri;font-size: 15px;text-align: left;box-sizing: border-box !important;overflow-wrap: break-word !important;">此文章非本原创，平台只是转载，供学习交流。</span><span style="outline: 0px;max-width: 100%;color: rgb(0, 0, 0);font-family: Calibri;font-size: 15px;text-align: left;box-sizing: border-box !important;overflow-wrap: break-word !important;">如无意侵犯版权，请联系删除。</span><span style="outline: 0px;max-width: 100%;color: rgb(0, 0, 0);font-family: Calibri;font-size: 15px;text-align: left;box-sizing: border-box !important;overflow-wrap: break-word !important;">编缉对上述内容保持中立，不对所包含内容的准确性、可靠性或完整性提供任何保证。本论坛</span><span style="outline: 0px;max-width: 100%;color: rgb(0, 0, 0);font-family: Calibri;font-size: 15px;text-align: left;box-sizing: border-box !important;overflow-wrap: break-word !important;">拥有对此声明的最终解释权。</span></span></section>
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