The article by Bill Wang and Alistair
Davidson "An
overview of major reforms in China’s regulatory environment" summarized the background about the regulatory environment in China.
It is widely recognized that China is currently the second largest pharmaceutical market in the world. Historically the regulatory environment in China has been considered a highly challenging one, with: (1) major issues in the areas of comparative quality between international standards and some local products and manufacturers; (2) a timeframe for review and approval of new drugs that is longer than most major countries; and (3) a lack of capacity in the regulatory bodies that has resulted in a backlog of applications. In August 2015, the China State Council issued “Opinions on Reforming the Review and Approval System for Drugs and Medical Devices.” This was partly a result of dialogue with the local and international pharma industry that, for many years, has been pressing for major regulatory reform.1 The overarching intention of this was to “promote the structural adjustment, transformation and upgrade of the pharmaceutical industry and bring marketed products up to international standards in terms of efficacy, safety and quality, so as to better meet the public needs for drugs.” The main practical aims are to: (1) eliminate the existing backlog of registration applications; (2) establish an environment for maximizing the quality of generic drugs; (3) create a framework in China that encourages research and development of new drugs in line with global development; and (4) improve the quality and increase transparency of the review and approval process.
- An Analysis Of Regulatory Reforms In China's Pharmaceutical Market
- New CFDA Requirements and its Implementation
- Q&A: Regulatory Reform in China
- The rewards of regulatory change Launching innovative biopharma in China
In the US, NIH’s ClinRegs
website contains the English version of the updates about the Chinese regulations
in clinical trials and drug development:
China
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US
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国家药品监督管理局（National Medical
Product Administration, NMPA）
It has just launched its English version website at http://subsites.chinadaily.com.cn/nmpa/drugs.html |
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国家药品监督管理局药品审评中心
(Center for Drug Evaluation)
|
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国家药品监督管理局医疗器械技术审评中心 (Center
for Medical Device Evaluation)
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Guidance, Guideline, and Policies Regarding Clinical Trials, Drug Development, Drug Approval (Links to the Chinese version and the translation of the titles in English)
上市后个例安全性报告（ICSRs）E2B（R3）实施指南
2019/05
|
Guidelines
for Post-marketing individual case safety reporting (ICSRs) E2B (R3)
|
药物研发与技术审评沟通交流管理办法
2018/09
|
Communications
for Drug Development and Technical Evaluation (Trial)
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接受药品境外临床试验数据的技术指导原则 2018/07
|
Guidance
for Accepting Data from Foreign Clinical Trials
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药品试验数据保护实施办法
2018/04
|
Data
Protection in Clinical Trials for Drug
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关于鼓励药品创新实现优先审评审批的意见
2017/12
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Priority
Review & Approval Procedure
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药品注册受理审查指南
2017/11
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Guidelines
for Drug Application / Registration Submission
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关于调整进口药品注册管理有关事项的决定
2017/10
|
Decisions
on the Adjustment of Imported Drug Registration
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Pediatric
Extrapolation
|
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药物临床试验的一般考虑指导原则 2017/01
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General
Considerations to Clinical Trials for Drug
|
|
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Bioequivalence
Evaluation for Generic Drugs
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Data
Management Planning and Reporting of Statistical Analysis
|
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药物临床试验的生物统计学指导原则
2016/06
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Biostatistics
Principles for Clinical Trials
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临床试验数据管理工作技术指南
2016/07
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Data
Management Procedure for Clinical Trials
|
儿科人群药物临床试验技术指导原则 2016/03
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Clinical
Trials in Pediatric Population
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关于开展药物临床试验数据自查核查工作的公告
2015/07
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Self-inspection
of Clinical Trial Data
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临床试验的电子数据采集技术指导原则
2015/07
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Electronic
Data Capture for Clinical Trials
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国际多中心临床试验指南 2015/01
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Multi-regional
Clinical Trial
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Clinical
Trial Registry
|
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药品不良反应报告和监测管理办法
2011/07
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Adverse
Drug Reaction Reporting and Monitoring
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药物临床试验质量管理规范 2003/09
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Guidance
for Quality Control in Clinical Trials
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