GCP: A Question & Answer Reference Guide China Food and Drug Administration (CFDA) Procedures for the Administration of Pharmaceuticals Registration (1) Chapter 1 General Principles Chapter 2 Basic Requirements Chapter 3 Clinical Study of Drugs Chapter 4 Application and Approval of New Drugs Chapter 5 Application and Approval of Generic drugs Chapter 6 Application and Approval for Import Drugs Chapter 7 Application and Approval for OTC Drugs Chapter 8 Supplemental Application for Drug Registration Chapter 9 Re-registration of Drugs Chapter 10 Inspection During Drug Registration Chapter 11 Drug Registration Standards and Insert Sheet Chapter 12 Prescribed Timeline Chapter 13 Reconsideration Chapter 14 Legal Liability Chapter 15 Miscellaneous Annex 1 Registration Categories and Application Information Requirements of TCM and Natural Drugs Annex 2 Registration Categories and Application Information Requirements of Chemical Drugs Annex 3 Registration Categories and Application Information Items Requirements of Biological Products Annex 4 Registration Items and Application Information Requirements of Supplemental Application of Drug Registration Annex 5 Application Information Items of Drug Re-Registration Annex 6 Timeframe for monitoring period of New Drugs Chapter 3 of the regulation provides a framework for the conduct of clinical trials within China, and authorizes clinical trials to be conducted in China in accordance with GCP. For a foreign drug to be accepted under a marketing application, the drug company must conduct at least one Phase II and/or Phase III clinical trial in China. This clinical trial requirement may be met through an international multi-center trial that features at least one trial center based within China. Decisions regarding the acceptability of clinical trial programs in support of marketing applications in China are made by the CFDA. The CFDA retains the right to require that a Phase I clinical trial also be conducted within China. For any sponsor who wishes to submit a drug registration application in China, the following preconditions must be reached: * Domestic applicant should be the one who is legally registering and can independently undertake civil responsibility in China. * Foreign applicant should be the pharmaceutical company that has a legal registration in the local territory. The foreign applicant that is applying import drug registration should transact the process by its Chinese administrative branch or an agency the company entrusts to be the legal representative. * The branch or agency that supports the overseas company to process the drug registration should have adequate specialized knowledge and be familiar with the law, guidance and technique requirements of drug regulations. Moreover, to reach the point at which a foreign company can submit a clinical trial authorization request of a drug in China, at least one of two conditions must apply: (1) the drug was launched outside of China ; or (2) the drug has not yet been approved for marketing outside of China, but the drug is being researched in a Phase II or III clinical trial outside of China. Local Chinese drug companies must register a drug with the CFDA and receive authorization to conduct Phase I, Phase II and Phase III clinical trials. It is important to note that China's GCP regulations and guidance require that both Western-style "classical" clinical trials and traditional Chinese medicine (TCM) clinical trials adhere to the same standards. Chinese regulations and guidelines also address many areas relevant to the clinical research process, including the following: 600