FDA建立与申请人沟通的会议制度的经验对我国新药审批的启示

摘要

新药的开发和审批是一个系统而复杂的科学过程。在此过程中，申办者和审评人员对新药的安全性、有效性和质量等特性和审批要求的了解程度和方式以及角度是不同的，这会导致新药研究开发进展缓慢、风险增大、审批结果不可预测及审批时间延长等诸多问题。因此，建立有效的双方沟通交流渠道是必要而且重要的。

FDA从1997年实施的PDUFA II开始积极探索在新药研究开发和审批过程中建立与申办者和/或申请人沟通交流的正式会议制度，并从法律和法规层面对正式会议制度进行了规范。FDA在其指南文件中对正式会议的类型、请求、评估、会议资料的要求和提交、召开会议的程序、会议纪要的整理等均作了详细规定。申办者可以在IND提交前、I期试验结束、IIa期试验结束、II期试验结束、NDA/BLA提交前等新药开发的关键环节申请正式会议。调查数据表明，这些会议对提高新药开发的质量和上市申请的质量是非常关键的。会议制度化加快了新药的开发，有效地缩短了新药审批时间，节约了开发成本，同时也减少了无效浪费。

国家食品药品监督管理局已建立了多种对申请人的咨询沟通途径，但现有的沟通渠道还存在一定的局限性和问题，还未形成对新药开发和审批的有效促进作用。在中国近期内实行SFDA(CDE)与申请人沟通会议制度化是非常必要的，而且是可行的。

关键词： 新药开发和审批；

正式会议；

FDA

沟通交流会议制度； 国家食品药品监督管理局；

I

FDA’s Experience in Establishing Meeting System for Communication With Sponsors or Applicants and Its Illumination on Chinese New Drug Review and Approval

System Abstract

Development and review of a new drug is a systemic, complicated, and science-based process. The sponsors and reviewers comprehend the new drug’s characteristics related to its safety, efficacy and quality, and technical requirements for approval with different approaches, viewpoints and degree during this process. These differences may lead to many problems such as slow progress of new drug development, enlarged risks, unpredictable review results and prolonged review process, etc. Therefore, it is necessary and important to establish the efficient communication channel between sponsors/applicants and reviewers.

With the implementation of PDUFA II in 1997, FDA explored to establish the formal meeting system to communicate with the sponsors during development and review process of a new drug, and regulated it with law and regulations. FDA prescribes the types of meetings, procedures for requesting meetings, content of information packages, procedures for the conduct of meetings, and documentation in details in the Guidance. The sponsors can apply for the formal meeting at critical milestones in drug development, such as pre-IND, end of phase 1, end of phase 2a, end of phase 2, pre- BLA or NDA, etc. Survey data showed that these meetings are critical for improving the quality of development and marketing application. The systemic meeting sped up the new drug development, shortened the review time, saved the development cost, and reduced the useless waste.

SFDA set up many channels to communicate with the applicants, but there are some limitation and issues at current channels. These communication channels didn’t improve the development and review of new drugs yet. It is necessary and feasible for SFDA actualizing meeting system for communication with the applicants in the near future.

Key Words: Development and Review of New Drug; Meeting System for Communication;

Formal Meeting;

SFDA;

FDA;

II

目录

第1章 序言 ................................................................................................................................................. 1 第2章

FDA建立会议制度的背景、法规依据和指南文件 ................................................................... 2

2.1 会议制度产生的历史背景 ....................................................... 2 2.2 会议制度的法律和法规依据 ..................................................... 3 2.3 与会议制度有关的指南文件 ..................................................... 6 第3章

FDA与申办者或申请人的正式会议制度介绍 ........................................................................... 7

3.1 会议类型 ..................................................................... 7 3.2 申办者或申请人提出会议请求 ................................................... 8 3.3 FDA对会议请求的评估 ........................................................ 10 3.4 会议调整和取消 .............................................................. 10 3.5 会议资料包的内容和提交 ...................................................... 11 3.6 预会议和与申办者或申请人的沟通 .............................................. 13 3.7 召开会议的程序 .............................................................. 13 3.8 文件整理 .................................................................... 14 3.9 对会议纪要的争议的解决 ...................................................... 14 第4章

FDA与申办者在新药开发的关键环节举行的会议 ................................................................. 14

4.1 IND提交前会议 .............................................................. 15 4.2 1期结束时会议 .............................................................. 18 4.3 2A期结束时会议 .............................................................. 18 4.4 2期结束会议 ................................................................ 18 4.5 NDA/BLA提交前会议 .......................................................... 19 第5章 第6章

FDA实行的正式会议制度对新药审批的影响 ......................................................................... 20 中国SFDA在新药审批过程中与申请人沟通的现状及影响 ................................................. 25

6.1 SFDA药品审评中心与注册申请人沟通的现状 ..................................... 25 6.2 现有的沟通渠道的局限性和存在的问题 .......................................... 26 6.3 现有的沟通方式和渠道对新药审评过程的影响 .................................... 27 第7章

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