Dr Dequan Ren, China
Traditional Chinese medicines (TCMs) play an important role in the Chinese primary health care system, with 1249 TCMs listed in the national Essential Drugs List. The sales of TCMs over the past year amounted to about US$ 9.8 billion.
There are national quality standards for marketed drugs, including those of the Pharmacopoeia and Propharmacopoeia. The progress and achievements in respect of quality control are reflected in the current edition of the Pharmacopoeia. Under the Drug Administration Law (1985), marketing authorization is required for all drugs; this authorization is issued by the drug regulatory authority after a strict evaluation process. In 1985, provisions for the approval of new TCMs were issued. Under these provisions, products marketed before 1986 can remain on the market if no adverse events have been reported. With effect from 1986, the process for approval of new TCMs is divided into two steps: approval for clinical trial and approval for marketing. In an application for drug registration, general data, pharmaceutical data, pharmacological and toxicological data, and clinical data have to be submitted.
All TCM manufacturers and commercial enterprises must be certified and registered by the local drug regulatory authorities. Good Manufacturing Practices (GMP) and Good Supplies Practices (GSP) are fundamental requirements for TCM manufacturers and commercial enterprises. GMP certification has been conducted since 1995. Currently, there are 1276 manufacturers with GMP certification, of which 184 are TCM manufacturers. As from 30 June 2004, manufacturers who fail to comply with GMP will not be allowed to manufacture medicines. GSP was promulgated in 2000 and is under trial implementation. The State Drug Administration (SDA) initiates GSP certifications for commercial enterprises. Currently, 67 commercial enterprises have been so certified.
Good Clinical Practice (GCP) was promulgated by SDA in 1999. All clinical trials should be conducted in line with GCP. There are 165 hospitals appointed as clinical trial sites, of which 40 are also TCM clinical trial sites. The applicants can choose the sites for their clinical trials.
Good Laboratory Practices (GLP) was formally promulgated by SDA in 1999. Toxicology and pharmacology studies of TCMs should be conducted in line with GLP. Institutions doing toxicology and pharmacology studies will be certified by SDA according to GLP. For applications for registration of new drugs, the toxicology and pharmacology data used must be from certified institutions only.
The following new measures are being taken to strengthen the management and to promote the development of TCMs:
• Good Agricultural Practices will be promulgated and implemented.
• A registration system for processed products and crude drugs will gradually be implemented. TCM quality standards should be improved.
• Quality standards of TCMs will be improved using fingerprinting technologies, such as fingerprinting chromatography.
• The efficacy of TCMs should be reviewed using modern techniques, not only in comparison with western medicine but also with TCM theory.
• International cooperation and communication should be improved.