China's Regulations on Drug and Biological Products Registration

In China, drug and biological products are regulated by SFDA (国家食品药品监督管理局). sFDA is a counterpart of US FDA. Its Center for Drug Evaluation (药品审评中心) regulates both drug and biological products (sort of combination of US FDA's CDER and CBER divisions).

Law and Guidance:

Drug Administration Law: Dec 2001

• All clinical trials should be pre-approved by sFDA 
• All clinical trials should be carried out by qualified investigators 
• Detailed procedures and technical data should be submitted 

Regulations for Implementation of the Drug Administration Law: Sep 2002

Good Clinical Practice: Aug 2003 (In Chinese)

Statistical Guidelines for Clinical Trials of Drugs and Biologics: Mar 2005 (in Chinese)

Pharmacokinetics and Bioequivalence: 2005 (化学药物制剂人体生物利用度和生物等小等效性研究技术指导原则)

Toxicology: 2005 (化学药物长期毒性试验技术指导原则)

Hong Kong; GCP for Proprietary Chinese Medicines: Feb 2004 (PDF669KB)

Drug Registration Regulation (药品注册管理办法): Jul 2007 and its appendices

•   It is interesting that in its appendices, there are requirements for sample size. For a new or an imported drug applications, the sample size should meet the statistical requirement and the minimal cases required.  For category I and II (new drugs), the minimal cases required (trial group exposure): 20-30 for Phase I, 100 for Phase II, 300 for Phase III, 2000 for Phase IV.  For category III and IV (imported drugs), trials should have at least 100 pairs. In the event of more than one indication, cases for each main indication shall be at least 60 pairs.

Further reading:

• Chen, Feng, Chen, Qiguang, Yu, Hao, Chen, Jie, Hsu, Jason (2008). Current statistical requirements for pharmaceutical clinical trials In China. Drug Information Journal 42, pp. 321-330.