Sunday, July 14, 2019

Regulations for Clinical Trials, Drug Development, Drug Approvals in China


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.
 Additional discussions about the regulatory environment in China for clinical trials and drug development can be found here:

Chinese regulatory agencies have published a flurry of regulations about the clinical trials and drug approval processes. Unfortunately, all regulatory guidance and policies are in Chinese. 

In the US, NIH’s ClinRegs website contains the English version of the updates about the Chinese regulations in clinical trials and drug development:



Regulatory Authorities in China and the US 

China
US
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

国家药品监督管理局药品审评中心 (Center for Drug Evaluation)

国家药品监督管理局医疗器械技术审评中心 (Center for Medical Device Evaluation)


Guidance, Guideline, and Policies Regarding Clinical Trials, Drug Development, Drug Approval (Links to the Chinese version and the translation of the titles in English)

Guidelines for Post-marketing individual case safety reporting (ICSRs) E2B (R3)
Communications for Drug Development and Technical Evaluation (Trial)
Guidance for Accepting Data from Foreign Clinical Trials
Data Protection in Clinical Trials for Drug

Priority Review & Approval Procedure


Guidelines for Drug Application / Registration Submission
Decisions on the Adjustment of Imported Drug Registration
Pediatric Extrapolation

General Considerations to Clinical Trials for Drug

Bioequivalence Evaluation for Generic Drugs
Data Management Planning and Reporting of Statistical Analysis
Biostatistics Principles for Clinical Trials

Data Management Procedure for Clinical Trials
Clinical Trials in Pediatric Population
Self-inspection of Clinical Trial Data
Electronic Data Capture for Clinical Trials
Multi-regional Clinical Trial
Clinical Trial Registry
Adverse Drug Reaction Reporting and Monitoring
Guidance for Quality Control in Clinical Trials

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