3.临床试验实施
# 3.临床试验实施
> 共 **52** 个PDF文件
## 3.1伦理审查
- [20101108_关于印发药物临床试验伦理审查工作指导原则的通知国食药监注[2010]436号](/upload/20101108_%E5%85%B3%E4%BA%8E%E5%8D%B0%E5%8F%91%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E4%BC%A6%E7%90%86%E5%AE%A1%E6%9F%A5%E5%B7%A5%E4%BD%9C%E6%8C%87%E5%AF%BC%E5%8E%9F%E5%88%99%E7%9A%84%E9%80%9A%E7%9F%A5%E5%9B%BD%E9%A3%9F%E8%8D%AF%E7%9B%91%E6%B3%A8%5B2010%5D436%E5%8F%B7.pdf)
- [20161021_NHC_关于《涉及人的生物医学研究伦理审查办法》的解读](/upload/20161021_NHC_%E5%85%B3%E4%BA%8E%E3%80%8A%E6%B6%89%E5%8F%8A%E4%BA%BA%E7%9A%84%E7%94%9F%E7%89%A9%E5%8C%BB%E5%AD%A6%E7%A0%94%E7%A9%B6%E4%BC%A6%E7%90%86%E5%AE%A1%E6%9F%A5%E5%8A%9E%E6%B3%95%E3%80%8B%E7%9A%84%E8%A7%A3%E8%AF%BB.pdf)
- [20161104_NHC_涉及人的生物医学研究伦理审查办法](/upload/20161104_NHC_%E6%B6%89%E5%8F%8A%E4%BA%BA%E7%9A%84%E7%94%9F%E7%89%A9%E5%8C%BB%E5%AD%A6%E7%A0%94%E7%A9%B6%E4%BC%A6%E7%90%86%E5%AE%A1%E6%9F%A5%E5%8A%9E%E6%B3%95.pdf)
- [20220320_SC_中共中央办公厅国务院办公厅印发《关于加强科技伦理治理的意见》](/upload/20220320_SC_%E4%B8%AD%E5%85%B1%E4%B8%AD%E5%A4%AE%E5%8A%9E%E5%85%AC%E5%8E%85%E5%9B%BD%E5%8A%A1%E9%99%A2%E5%8A%9E%E5%85%AC%E5%8E%85%E5%8D%B0%E5%8F%91%E3%80%8A%E5%85%B3%E4%BA%8E%E5%8A%A0%E5%BC%BA%E7%A7%91%E6%8A%80%E4%BC%A6%E7%90%86%E6%B2%BB%E7%90%86%E7%9A%84%E6%84%8F%E8%A7%81%E3%80%8B.pdf)
### 3.2.1通用
- [19980610_SC_人类遗传资源管理暂行办法](/upload/19980610_SC_%E4%BA%BA%E7%B1%BB%E9%81%97%E4%BC%A0%E8%B5%84%E6%BA%90%E7%AE%A1%E7%90%86%E6%9A%82%E8%A1%8C%E5%8A%9E%E6%B3%95.pdf)
- [20150930_MOST_科技部办公厅关于实施人类遗传资源采集、收集、买卖、出口、出境行政许可的通知](/upload/20150930_MOST_%E7%A7%91%E6%8A%80%E9%83%A8%E5%8A%9E%E5%85%AC%E5%8E%85%E5%85%B3%E4%BA%8E%E5%AE%9E%E6%96%BD%E4%BA%BA%E7%B1%BB%E9%81%97%E4%BC%A0%E8%B5%84%E6%BA%90%E9%87%87%E9%9B%86%E3%80%81%E6%94%B6%E9%9B%86%E3%80%81%E4%B9%B0%E5%8D%96%E3%80%81%E5%87%BA%E5%8F%A3%E3%80%81%E5%87%BA%E5%A2%83%E8%A1%8C%E6%94%BF%E8%AE%B8%E5%8F%AF%E7%9A%84%E9%80%9A%E7%9F%A5.pdf)
- [20171027_MOST_科技部办公厅关于优化人类遗传资源行政审批流程的通知](/upload/20171027_MOST_%E7%A7%91%E6%8A%80%E9%83%A8%E5%8A%9E%E5%85%AC%E5%8E%85%E5%85%B3%E4%BA%8E%E4%BC%98%E5%8C%96%E4%BA%BA%E7%B1%BB%E9%81%97%E4%BC%A0%E8%B5%84%E6%BA%90%E8%A1%8C%E6%94%BF%E5%AE%A1%E6%89%B9%E6%B5%81%E7%A8%8B%E7%9A%84%E9%80%9A%E7%9F%A5.pdf)
- [20190610_SC_中华人民共和国人类遗传资源管理条例（中华人民共和国国务院令第717号）](/upload/20190610_SC_%E4%B8%AD%E5%8D%8E%E4%BA%BA%E6%B0%91%E5%85%B1%E5%92%8C%E5%9B%BD%E4%BA%BA%E7%B1%BB%E9%81%97%E4%BC%A0%E8%B5%84%E6%BA%90%E7%AE%A1%E7%90%86%E6%9D%A1%E4%BE%8B%EF%BC%88%E4%B8%AD%E5%8D%8E%E4%BA%BA%E6%B0%91%E5%85%B1%E5%92%8C%E5%9B%BD%E5%9B%BD%E5%8A%A1%E9%99%A2%E4%BB%A4%E7%AC%AC717%E5%8F%B7%EF%BC%89.pdf)
- [20200107_MOST_中国人类遗传资源管理办公室关于对部分行政审批项目实施简化审批流程的通知](/upload/20200107_MOST_%E4%B8%AD%E5%9B%BD%E4%BA%BA%E7%B1%BB%E9%81%97%E4%BC%A0%E8%B5%84%E6%BA%90%E7%AE%A1%E7%90%86%E5%8A%9E%E5%85%AC%E5%AE%A4%E5%85%B3%E4%BA%8E%E5%AF%B9%E9%83%A8%E5%88%86%E8%A1%8C%E6%94%BF%E5%AE%A1%E6%89%B9%E9%A1%B9%E7%9B%AE%E5%AE%9E%E6%96%BD%E7%AE%80%E5%8C%96%E5%AE%A1%E6%89%B9%E6%B5%81%E7%A8%8B%E7%9A%84%E9%80%9A%E7%9F%A5.pdf)
- [20200616_MOST_中国人类遗传资源管理办公室关于提交保藏年度报告以及国际合作科学研究总结报告的通知](/upload/20200616_MOST_%E4%B8%AD%E5%9B%BD%E4%BA%BA%E7%B1%BB%E9%81%97%E4%BC%A0%E8%B5%84%E6%BA%90%E7%AE%A1%E7%90%86%E5%8A%9E%E5%85%AC%E5%AE%A4%E5%85%B3%E4%BA%8E%E6%8F%90%E4%BA%A4%E4%BF%9D%E8%97%8F%E5%B9%B4%E5%BA%A6%E6%8A%A5%E5%91%8A%E4%BB%A5%E5%8F%8A%E5%9B%BD%E9%99%85%E5%90%88%E4%BD%9C%E7%A7%91%E5%AD%A6%E7%A0%94%E7%A9%B6%E6%80%BB%E7%BB%93%E6%8A%A5%E5%91%8A%E7%9A%84%E9%80%9A%E7%9F%A5.pdf)
- [20200820_MOST_中国人类遗传资源管理办公室关于进一步扩大简化审批流程实施范围的通知](/upload/20200820_MOST_%E4%B8%AD%E5%9B%BD%E4%BA%BA%E7%B1%BB%E9%81%97%E4%BC%A0%E8%B5%84%E6%BA%90%E7%AE%A1%E7%90%86%E5%8A%9E%E5%85%AC%E5%AE%A4%E5%85%B3%E4%BA%8E%E8%BF%9B%E4%B8%80%E6%AD%A5%E6%89%A9%E5%A4%A7%E7%AE%80%E5%8C%96%E5%AE%A1%E6%89%B9%E6%B5%81%E7%A8%8B%E5%AE%9E%E6%96%BD%E8%8C%83%E5%9B%B4%E7%9A%84%E9%80%9A%E7%9F%A5.pdf)
- [20201021_MOST_中国人类遗传资源管理办公室关于进一步扩大简化审批流程实施范围的通知](/upload/20201021_MOST_%E4%B8%AD%E5%9B%BD%E4%BA%BA%E7%B1%BB%E9%81%97%E4%BC%A0%E8%B5%84%E6%BA%90%E7%AE%A1%E7%90%86%E5%8A%9E%E5%85%AC%E5%AE%A4%E5%85%B3%E4%BA%8E%E8%BF%9B%E4%B8%80%E6%AD%A5%E6%89%A9%E5%A4%A7%E7%AE%80%E5%8C%96%E5%AE%A1%E6%89%B9%E6%B5%81%E7%A8%8B%E5%AE%9E%E6%96%BD%E8%8C%83%E5%9B%B4%E7%9A%84%E9%80%9A%E7%9F%A5.pdf)
- [20220304_MOST_关于更新人类遗传资源管理常见问题解答的通知](/upload/20220304_MOST_%E5%85%B3%E4%BA%8E%E6%9B%B4%E6%96%B0%E4%BA%BA%E7%B1%BB%E9%81%97%E4%BC%A0%E8%B5%84%E6%BA%90%E7%AE%A1%E7%90%86%E5%B8%B8%E8%A7%81%E9%97%AE%E9%A2%98%E8%A7%A3%E7%AD%94%E7%9A%84%E9%80%9A%E7%9F%A5.pdf)
- [20220415_MOST_关于更新人类遗传资源管理常见问题解答（系列问答二）的通知](/upload/20220415_MOST_%E5%85%B3%E4%BA%8E%E6%9B%B4%E6%96%B0%E4%BA%BA%E7%B1%BB%E9%81%97%E4%BC%A0%E8%B5%84%E6%BA%90%E7%AE%A1%E7%90%86%E5%B8%B8%E8%A7%81%E9%97%AE%E9%A2%98%E8%A7%A3%E7%AD%94%EF%BC%88%E7%B3%BB%E5%88%97%E9%97%AE%E7%AD%94%E4%BA%8C%EF%BC%89%E7%9A%84%E9%80%9A%E7%9F%A5.pdf)
- [20220711_MOST_关于人类遗传资源信息备份平台迁移及更名的公告](/upload/20220711_MOST_%E5%85%B3%E4%BA%8E%E4%BA%BA%E7%B1%BB%E9%81%97%E4%BC%A0%E8%B5%84%E6%BA%90%E4%BF%A1%E6%81%AF%E5%A4%87%E4%BB%BD%E5%B9%B3%E5%8F%B0%E8%BF%81%E7%A7%BB%E5%8F%8A%E6%9B%B4%E5%90%8D%E7%9A%84%E5%85%AC%E5%91%8A.pdf)
- [20230601_MOST_科学技术部令第21号人类遗传资源管理条例实施细则](/upload/20230601_MOST_%E7%A7%91%E5%AD%A6%E6%8A%80%E6%9C%AF%E9%83%A8%E4%BB%A4%E7%AC%AC21%E5%8F%B7%E4%BA%BA%E7%B1%BB%E9%81%97%E4%BC%A0%E8%B5%84%E6%BA%90%E7%AE%A1%E7%90%86%E6%9D%A1%E4%BE%8B%E5%AE%9E%E6%96%BD%E7%BB%86%E5%88%99.pdf)
### 3.2.2生物制品
- [20201017_NPC_中华人民共和国生物安全法](/upload/20201017_NPC_%E4%B8%AD%E5%8D%8E%E4%BA%BA%E6%B0%91%E5%85%B1%E5%92%8C%E5%9B%BD%E7%94%9F%E7%89%A9%E5%AE%89%E5%85%A8%E6%B3%95.pdf)
## 3.3临床试验登记
- [20130906_NMPA_关于药物临床试验信息平台的公告（第28号）](/upload/20130906_NMPA_%E5%85%B3%E4%BA%8E%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E4%BF%A1%E6%81%AF%E5%B9%B3%E5%8F%B0%E7%9A%84%E5%85%AC%E5%91%8A%EF%BC%88%E7%AC%AC28%E5%8F%B7%EF%BC%89.pdf)
- [20130918_NMPA_总局实施药物临床试验登记与信息公示](/upload/20130918_NMPA_%E6%80%BB%E5%B1%80%E5%AE%9E%E6%96%BD%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E7%99%BB%E8%AE%B0%E4%B8%8E%E4%BF%A1%E6%81%AF%E5%85%AC%E7%A4%BA.pdf)
- [20151201_NMPA_关于化学药生物等效性试验实行备案管理的公告（2015年第257号）](/upload/20151201_NMPA_%E5%85%B3%E4%BA%8E%E5%8C%96%E5%AD%A6%E8%8D%AF%E7%94%9F%E7%89%A9%E7%AD%89%E6%95%88%E6%80%A7%E8%AF%95%E9%AA%8C%E5%AE%9E%E8%A1%8C%E5%A4%87%E6%A1%88%E7%AE%A1%E7%90%86%E7%9A%84%E5%85%AC%E5%91%8A%EF%BC%882015%E5%B9%B4%E7%AC%AC257%E5%8F%B7%EF%BC%89.pdf)
- [20200701_CDE_关于发布《药物临床试验登记与信息公示管理规范（试行）》的通告（2020年第9号）](/upload/20200701_CDE_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E3%80%8A%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E7%99%BB%E8%AE%B0%E4%B8%8E%E4%BF%A1%E6%81%AF%E5%85%AC%E7%A4%BA%E7%AE%A1%E7%90%86%E8%A7%84%E8%8C%83%EF%BC%88%E8%AF%95%E8%A1%8C%EF%BC%89%E3%80%8B%E7%9A%84%E9%80%9A%E5%91%8A%EF%BC%882020%E5%B9%B4%E7%AC%AC9%E5%8F%B7%EF%BC%89.pdf)
- [20200710_CDE_关于上线新版药物临床试验登记与信息公示平台系统的通知](/upload/20200710_CDE_%E5%85%B3%E4%BA%8E%E4%B8%8A%E7%BA%BF%E6%96%B0%E7%89%88%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E7%99%BB%E8%AE%B0%E4%B8%8E%E4%BF%A1%E6%81%AF%E5%85%AC%E7%A4%BA%E5%B9%B3%E5%8F%B0%E7%B3%BB%E7%BB%9F%E7%9A%84%E9%80%9A%E7%9F%A5.pdf)
## 3.4试验符合性
- [20140904_NMPA_关于香港特别行政区三家医疗机构承担内地药物临床试验有关事宜的公告（2014年第42号）](/upload/20140904_NMPA_%E5%85%B3%E4%BA%8E%E9%A6%99%E6%B8%AF%E7%89%B9%E5%88%AB%E8%A1%8C%E6%94%BF%E5%8C%BA%E4%B8%89%E5%AE%B6%E5%8C%BB%E7%96%97%E6%9C%BA%E6%9E%84%E6%89%BF%E6%8B%85%E5%86%85%E5%9C%B0%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%9C%89%E5%85%B3%E4%BA%8B%E5%AE%9C%E7%9A%84%E5%85%AC%E5%91%8A%EF%BC%882014%E5%B9%B4%E7%AC%AC42%E5%8F%B7%EF%BC%89.pdf)
- [20160425_NMPA_关于台湾地区四家医疗机构承接药物临床试验有关事宜的公告（2016年第87号）](/upload/20160425_NMPA_%E5%85%B3%E4%BA%8E%E5%8F%B0%E6%B9%BE%E5%9C%B0%E5%8C%BA%E5%9B%9B%E5%AE%B6%E5%8C%BB%E7%96%97%E6%9C%BA%E6%9E%84%E6%89%BF%E6%8E%A5%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%9C%89%E5%85%B3%E4%BA%8B%E5%AE%9C%E7%9A%84%E5%85%AC%E5%91%8A%EF%BC%882016%E5%B9%B4%E7%AC%AC87%E5%8F%B7%EF%BC%89.pdf)
- [20160531_NMPA_关于药物非临床研究质量管理规范认证和药物临床试验机构资格认定施行电子申请受理的公告（2016年第110号）](/upload/20160531_NMPA_%E5%85%B3%E4%BA%8E%E8%8D%AF%E7%89%A9%E9%9D%9E%E4%B8%B4%E5%BA%8A%E7%A0%94%E7%A9%B6%E8%B4%A8%E9%87%8F%E7%AE%A1%E7%90%86%E8%A7%84%E8%8C%83%E8%AE%A4%E8%AF%81%E5%92%8C%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%9C%BA%E6%9E%84%E8%B5%84%E6%A0%BC%E8%AE%A4%E5%AE%9A%E6%96%BD%E8%A1%8C%E7%94%B5%E5%AD%90%E7%94%B3%E8%AF%B7%E5%8F%97%E7%90%86%E7%9A%84%E5%85%AC%E5%91%8A%EF%BC%882016%E5%B9%B4%E7%AC%AC110%E5%8F%B7%EF%BC%89.pdf)
- [20160802_NMPA_关于香港特别行政区两家医疗机构新增专业承担内地药物临床试验有关事宜的公告（2016年第127号）](/upload/20160802_NMPA_%E5%85%B3%E4%BA%8E%E9%A6%99%E6%B8%AF%E7%89%B9%E5%88%AB%E8%A1%8C%E6%94%BF%E5%8C%BA%E4%B8%A4%E5%AE%B6%E5%8C%BB%E7%96%97%E6%9C%BA%E6%9E%84%E6%96%B0%E5%A2%9E%E4%B8%93%E4%B8%9A%E6%89%BF%E6%8B%85%E5%86%85%E5%9C%B0%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%9C%89%E5%85%B3%E4%BA%8B%E5%AE%9C%E7%9A%84%E5%85%AC%E5%91%8A%EF%BC%882016%E5%B9%B4%E7%AC%AC127%E5%8F%B7%EF%BC%89.pdf)
- [20170802_NMPA_《药物非临床研究质量管理规范》解读](/upload/20170802_NMPA_%E3%80%8A%E8%8D%AF%E7%89%A9%E9%9D%9E%E4%B8%B4%E5%BA%8A%E7%A0%94%E7%A9%B6%E8%B4%A8%E9%87%8F%E7%AE%A1%E7%90%86%E8%A7%84%E8%8C%83%E3%80%8B%E8%A7%A3%E8%AF%BB.pdf)
- [20170802_NMPA_药物非临床研究质量管理规范（总局令第34号）](/upload/20170802_NMPA_%E8%8D%AF%E7%89%A9%E9%9D%9E%E4%B8%B4%E5%BA%8A%E7%A0%94%E7%A9%B6%E8%B4%A8%E9%87%8F%E7%AE%A1%E7%90%86%E8%A7%84%E8%8C%83%EF%BC%88%E6%80%BB%E5%B1%80%E4%BB%A4%E7%AC%AC34%E5%8F%B7%EF%BC%89.pdf)
- [20190430_NMPA_关于香港特别行政区四家医疗机构承担内地药物临床试验有关事宜的公告（2019年第36号）](/upload/20190430_NMPA_%E5%85%B3%E4%BA%8E%E9%A6%99%E6%B8%AF%E7%89%B9%E5%88%AB%E8%A1%8C%E6%94%BF%E5%8C%BA%E5%9B%9B%E5%AE%B6%E5%8C%BB%E7%96%97%E6%9C%BA%E6%9E%84%E6%89%BF%E6%8B%85%E5%86%85%E5%9C%B0%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%9C%89%E5%85%B3%E4%BA%8B%E5%AE%9C%E7%9A%84%E5%85%AC%E5%91%8A%EF%BC%882019%E5%B9%B4%E7%AC%AC36%E5%8F%B7%EF%BC%89.pdf)
- [20191129_NMPA_关于发布药物临床试验机构管理规定的公告（2019年第101号）](/upload/20191129_NMPA_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%9C%BA%E6%9E%84%E7%AE%A1%E7%90%86%E8%A7%84%E5%AE%9A%E7%9A%84%E5%85%AC%E5%91%8A%EF%BC%882019%E5%B9%B4%E7%AC%AC101%E5%8F%B7%EF%BC%89.pdf)
- [20191129_NMPA_综合司关于做好药物临床试验机构备案工作的通知（药监综药注〔2019〕100号）](/upload/20191129_NMPA_%E7%BB%BC%E5%90%88%E5%8F%B8%E5%85%B3%E4%BA%8E%E5%81%9A%E5%A5%BD%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%9C%BA%E6%9E%84%E5%A4%87%E6%A1%88%E5%B7%A5%E4%BD%9C%E7%9A%84%E9%80%9A%E7%9F%A5%EF%BC%88%E8%8D%AF%E7%9B%91%E7%BB%BC%E8%8D%AF%E6%B3%A8%E3%80%942019%E3%80%95100%E5%8F%B7%EF%BC%89.pdf)
- [20200426_NMPA_关于发布药物临床试验质量管理规范的公告（2020年第57号）](/upload/20200426_NMPA_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E8%B4%A8%E9%87%8F%E7%AE%A1%E7%90%86%E8%A7%84%E8%8C%83%E7%9A%84%E5%85%AC%E5%91%8A%EF%BC%882020%E5%B9%B4%E7%AC%AC57%E5%8F%B7%EF%BC%89.pdf)
- [20200429_NMPA_《药物临床试验质量管理规范》解读](/upload/20200429_NMPA_%E3%80%8A%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E8%B4%A8%E9%87%8F%E7%AE%A1%E7%90%86%E8%A7%84%E8%8C%83%E3%80%8B%E8%A7%A3%E8%AF%BB-VEXO.pdf)
- [20200701_NMPA_关于发布药品记录与数据管理要求（试行）的公告（2020年第74号）](/upload/20200701_NMPA_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E8%8D%AF%E5%93%81%E8%AE%B0%E5%BD%95%E4%B8%8E%E6%95%B0%E6%8D%AE%E7%AE%A1%E7%90%86%E8%A6%81%E6%B1%82%EF%BC%88%E8%AF%95%E8%A1%8C%EF%BC%89%E7%9A%84%E5%85%AC%E5%91%8A%EF%BC%882020%E5%B9%B4%E7%AC%AC74%E5%8F%B7%EF%BC%89-GyPH.pdf)
- [20200701_NMPA_药审中心关于发布《药物临床试验期间安全信息评估与管理规范（试行）》的通告（2020年第5号）](/upload/20200701_NMPA_%E8%8D%AF%E5%AE%A1%E4%B8%AD%E5%BF%83%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E3%80%8A%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%9C%9F%E9%97%B4%E5%AE%89%E5%85%A8%E4%BF%A1%E6%81%AF%E8%AF%84%E4%BC%B0%E4%B8%8E%E7%AE%A1%E7%90%86%E8%A7%84%E8%8C%83%EF%BC%88%E8%AF%95%E8%A1%8C%EF%BC%89%E3%80%8B%E7%9A%84%E9%80%9A%E5%91%8A%EF%BC%882020%E5%B9%B4%E7%AC%AC5%E5%8F%B7%EF%BC%89.pdf)
- [20201211_CDE_关于发布《药物研发与技术审评沟通交流管理办法》的通告（2020年第48号）](/upload/20201211_CDE_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E3%80%8A%E8%8D%AF%E7%89%A9%E7%A0%94%E5%8F%91%E4%B8%8E%E6%8A%80%E6%9C%AF%E5%AE%A1%E8%AF%84%E6%B2%9F%E9%80%9A%E4%BA%A4%E6%B5%81%E7%AE%A1%E7%90%86%E5%8A%9E%E6%B3%95%E3%80%8B%E7%9A%84%E9%80%9A%E5%91%8A%EF%BC%882020%E5%B9%B4%E7%AC%AC48%E5%8F%B7%EF%BC%89-qZRV.pdf)
- [20220104_CDE_关于发布《药物临床试验数据管理与统计分析计划指导原则》的通告（2021年第63号）](/upload/20220104_CDE_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E3%80%8A%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%95%B0%E6%8D%AE%E7%AE%A1%E7%90%86%E4%B8%8E%E7%BB%9F%E8%AE%A1%E5%88%86%E6%9E%90%E8%AE%A1%E5%88%92%E6%8C%87%E5%AF%BC%E5%8E%9F%E5%88%99%E3%80%8B%E7%9A%84%E9%80%9A%E5%91%8A%EF%BC%882021%E5%B9%B4%E7%AC%AC63%E5%8F%B7%EF%BC%89.pdf)
- [20220106_CDE_关于发布《“临床风险管理计划”撰写指导原则（试行）》的通告（2021年第68号）](/upload/20220106_CDE_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E3%80%8A%E2%80%9C%E4%B8%B4%E5%BA%8A%E9%A3%8E%E9%99%A9%E7%AE%A1%E7%90%86%E8%AE%A1%E5%88%92%E2%80%9D%E6%92%B0%E5%86%99%E6%8C%87%E5%AF%BC%E5%8E%9F%E5%88%99%EF%BC%88%E8%AF%95%E8%A1%8C%EF%BC%89%E3%80%8B%E7%9A%84%E9%80%9A%E5%91%8A%EF%BC%882021%E5%B9%B4%E7%AC%AC68%E5%8F%B7%EF%BC%89.pdf)
- [20220121_CDE_关于发布《药物临床试验中心化监查统计指导原则（试行）》的通告（2022年第11号）](/upload/20220121_CDE_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E3%80%8A%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E4%B8%AD%E5%BF%83%E5%8C%96%E7%9B%91%E6%9F%A5%E7%BB%9F%E8%AE%A1%E6%8C%87%E5%AF%BC%E5%8E%9F%E5%88%99%EF%BC%88%E8%AF%95%E8%A1%8C%EF%BC%89%E3%80%8B%E7%9A%84%E9%80%9A%E5%91%8A%EF%BC%882022%E5%B9%B4%E7%AC%AC11%E5%8F%B7%EF%BC%89.pdf)
- [20220527_NMPA_关于发布《药品生产质量管理规范（2010年修订）》临床试验用药品附录的公告（2022年第43号）](/upload/20220527_NMPA_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E3%80%8A%E8%8D%AF%E5%93%81%E7%94%9F%E4%BA%A7%E8%B4%A8%E9%87%8F%E7%AE%A1%E7%90%86%E8%A7%84%E8%8C%83%EF%BC%882010%E5%B9%B4%E4%BF%AE%E8%AE%A2%EF%BC%89%E3%80%8B%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E7%94%A8%E8%8D%AF%E5%93%81%E9%99%84%E5%BD%95%E7%9A%84%E5%85%AC%E5%91%8A%EF%BC%882022%E5%B9%B4%E7%AC%AC43%E5%8F%B7%EF%BC%89-eOQi.pdf)
- [20220623_CDE_关于发布《药物临床试验期间方案变更技术指导原则（试行）》的通告（2022年第34号）](/upload/20220623_CDE_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E3%80%8A%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%9C%9F%E9%97%B4%E6%96%B9%E6%A1%88%E5%8F%98%E6%9B%B4%E6%8A%80%E6%9C%AF%E6%8C%87%E5%AF%BC%E5%8E%9F%E5%88%99%EF%BC%88%E8%AF%95%E8%A1%8C%EF%BC%89%E3%80%8B%E7%9A%84%E9%80%9A%E5%91%8A%EF%BC%882022%E5%B9%B4%E7%AC%AC34%E5%8F%B7%EF%BC%89.pdf)
- [20221215_NMPA_关于药物非临床安全性评价研究机构信息平台上线运行的通告（2022年第58号）](/upload/20221215_NMPA_%E5%85%B3%E4%BA%8E%E8%8D%AF%E7%89%A9%E9%9D%9E%E4%B8%B4%E5%BA%8A%E5%AE%89%E5%85%A8%E6%80%A7%E8%AF%84%E4%BB%B7%E7%A0%94%E7%A9%B6%E6%9C%BA%E6%9E%84%E4%BF%A1%E6%81%AF%E5%B9%B3%E5%8F%B0%E4%B8%8A%E7%BA%BF%E8%BF%90%E8%A1%8C%E7%9A%84%E9%80%9A%E5%91%8A%EF%BC%882022%E5%B9%B4%E7%AC%AC58%E5%8F%B7%EF%BC%89.pdf)
- [20231103_NMPA_关于发布《药物临床试验机构监督检查办法（试行）》的通告（2023年第56号）](/upload/20231103_NMPA_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E3%80%8A%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%9C%BA%E6%9E%84%E7%9B%91%E7%9D%A3%E6%A3%80%E6%9F%A5%E5%8A%9E%E6%B3%95%EF%BC%88%E8%AF%95%E8%A1%8C%EF%BC%89%E3%80%8B%E7%9A%84%E9%80%9A%E5%91%8A%EF%BC%882023%E5%B9%B4%E7%AC%AC56%E5%8F%B7%EF%BC%89.pdf)
- [20240125_CFDI_关于发布《药物临床试验机构年度工作总结报告填报指南》的通告](/upload/20240125_CFDI_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E3%80%8A%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%9C%BA%E6%9E%84%E5%B9%B4%E5%BA%A6%E5%B7%A5%E4%BD%9C%E6%80%BB%E7%BB%93%E6%8A%A5%E5%91%8A%E5%A1%AB%E6%8A%A5%E6%8C%87%E5%8D%97%E3%80%8B%E7%9A%84%E9%80%9A%E5%91%8A.pdf)
## 3.5临床期间报告
- [20180427_CDE_关于发布《药物临床试验期间安全性数据快速报告的标准和程序》的通知](/upload/20180427_CDE_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E3%80%8A%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%9C%9F%E9%97%B4%E5%AE%89%E5%85%A8%E6%80%A7%E6%95%B0%E6%8D%AE%E5%BF%AB%E9%80%9F%E6%8A%A5%E5%91%8A%E7%9A%84%E6%A0%87%E5%87%86%E5%92%8C%E7%A8%8B%E5%BA%8F%E3%80%8B%E7%9A%84%E9%80%9A%E7%9F%A5.pdf)
- [20180603_CDE_关于《药物临床试验期间安全性数据快速报告标准和程序》有关事项的通知](/upload/20180603_CDE_%E5%85%B3%E4%BA%8E%E3%80%8A%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%9C%9F%E9%97%B4%E5%AE%89%E5%85%A8%E6%80%A7%E6%95%B0%E6%8D%AE%E5%BF%AB%E9%80%9F%E6%8A%A5%E5%91%8A%E6%A0%87%E5%87%86%E5%92%8C%E7%A8%8B%E5%BA%8F%E3%80%8B%E6%9C%89%E5%85%B3%E4%BA%8B%E9%A1%B9%E7%9A%84%E9%80%9A%E7%9F%A5.pdf)
- [20190411_CDE_关于发布《药物临床试验期间安全性数据快速报告常见问答（1.0版）》的通知](/upload/20190411_CDE_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E3%80%8A%E8%8D%AF%E7%89%A9%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E6%9C%9F%E9%97%B4%E5%AE%89%E5%85%A8%E6%80%A7%E6%95%B0%E6%8D%AE%E5%BF%AB%E9%80%9F%E6%8A%A5%E5%91%8A%E5%B8%B8%E8%A7%81%E9%97%AE%E7%AD%94%EF%BC%881.0%E7%89%88%EF%BC%89%E3%80%8B%E7%9A%84%E9%80%9A%E7%9F%A5.pdf)
- [20190426_CDE_关于药品审评中心网站开通“研发期间安全性相关报告递交”栏目的通知](/upload/20190426_CDE_%E5%85%B3%E4%BA%8E%E8%8D%AF%E5%93%81%E5%AE%A1%E8%AF%84%E4%B8%AD%E5%BF%83%E7%BD%91%E7%AB%99%E5%BC%80%E9%80%9A%E2%80%9C%E7%A0%94%E5%8F%91%E6%9C%9F%E9%97%B4%E5%AE%89%E5%85%A8%E6%80%A7%E7%9B%B8%E5%85%B3%E6%8A%A5%E5%91%8A%E9%80%92%E4%BA%A4%E2%80%9D%E6%A0%8F%E7%9B%AE%E7%9A%84%E9%80%9A%E7%9F%A5.pdf)
- [20200701_CDE_关于发布《研发期间安全性更新报告管理规范（试行）》的通告（2020年第7号）](/upload/20200701_CDE_%E5%85%B3%E4%BA%8E%E5%8F%91%E5%B8%83%E3%80%8A%E7%A0%94%E5%8F%91%E6%9C%9F%E9%97%B4%E5%AE%89%E5%85%A8%E6%80%A7%E6%9B%B4%E6%96%B0%E6%8A%A5%E5%91%8A%E7%AE%A1%E7%90%86%E8%A7%84%E8%8C%83%EF%BC%88%E8%AF%95%E8%A1%8C%EF%BC%89%E3%80%8B%E7%9A%84%E9%80%9A%E5%91%8A%EF%BC%882020%E5%B9%B4%E7%AC%AC7%E5%8F%B7%EF%BC%89.pdf)
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