Status Quo of Drug Supervision in China

IV. Supervision of Traditional Chinese Medicine and Folk Medicine

Traditional Chinese medicine (TCM) and folk medicine are special characteristics and advantages of Chinese medical science, and also important parts of the splendid culture of the Chinese nation. So far, more than 9,000 kinds of TCM preparations have been approved by the state to be sold on the market, and about 58,000 approval numbers have been granted. In 2007, the industrial output value of TCM reached 177.2 billion yuan, accounting for 26.53 percent of the total pharmaceutical industrial output value. The Chinese government attaches great importance to TCM's role in the prevention and treatment of diseases, has drawn up a series of administrative regulations and policies, works constantly to improve the supervision of TCM, and promotes the steady improvement of the quality of TCM.

Figure 4 Industrial Output Value of TCM 2000-2007

Constant improvement of the national TCM standards system. There are 7,014 national standards for TCM. Among them, the 2005 Pharmacopoeia of the People's Republic of China records 582 kinds of Chinese crude drugs, prepared slices of Chinese crude drugs, fats and extracts, as well as 564 kinds of TCM preparations. Standards made by the ministry and bureaus record 438 Chinese crude drugs and prepared slices of Chinese crude drugs, 4,690 TCM preparations, 308 crude folk drugs and 432 folk drug preparations. To ensure the safety and efficacy of TCM injections, and establish effective quality control methods, the state is enhancing the standardization of TCM injections. In 2000, the state launched the ?°Improvement of Quality Standards of TCM Injections with the Production Permission and Work on Fingerprints Chromatogram?±, and issued the Technological Requirements of Fingerprint Chromatogram Research of TCM Injections. At present, China is working hard to improve the safety and quality control and indices of 123 kinds of TCM injections sold on the market, fix the production areas of crude drugs of TCM injections, strictly control the quality of raw materials, intermediate products and finished products, and realize overall quality control for production and processing.

Adopting a TCM protection system. In 1992 the state issued the Regulations on the Protection of Traditional Chinese Medicines, to encourage research and development of TCM varieties for clinical practice, and exercise classified protection of TCM varieties with steady quality and proved curative effects. The TCM protection system has promoted the improvement of the overall quality of TCM, and related scientific and technological advancement, and boosts intensive TCM production. By the end of 2007, there were 2,469 kinds of TCM varieties under state protection.

Enhancing the management of Chinese crude drugs. The quality of Chinese crude drugs decides the quality of prepared slices of Chinese crude drugs and TCM preparations. The state has adopted comprehensive measures to enhance the management of Chinese crude drugs, protect TCM germ plasm and genetic resources, strengthen the selection and breeding of good varieties, and improve the quality of TCM from its sources. TCM databases and germ plasm resource databanks have been initially established and researches are being conducted into the protection of rare and endangered TCM resources. Endangered species, such as rhinoceros horn and tiger bone, are banned from being used as TCM ingredients while rare TCM resources, including natural musk and natural bezoar, are used within limited areas. The state is also conducting researches to find alternatives for rare and endangered TCM resources. We have realized the artificial cultivation of the main raw materials of prepared slices of Chinese crude drugs and TCM preparations, and are steadily developing standardized planting and industrialized production. In 2002 the state enacted the Good Agricultural Practices for Chinese Crude Drugs (trial) (GAP). At present, GAP certification has been implemented all over the country on a trial basis. The drug administration departments conduct on-the-spot inspections of enterprises which have applied for GAP certification. By the end of 2007, a total of 48 enterprises had passed GAP certification.

Heightening the production standards of prepared slices of Chinese crude drugs. The preparing of prepared slices of Chinese crude drugs is a characteristic technology of TCM production with geographic differences. The quality standards of prepared slices of Chinese crude drugs are included in the Pharmacopoeia of the People's Republic of China, Preparation Standards for Chinese Crude Drugs of the People's Republic of China and local standards. Since 2004, GMP (Good Manufacturing Practice) certification has been introduced, facilitating the modernization of prepared slices of Chinese crude drugs. By the end of 2007, a total of 343 enterprises had passed GMP certification. And from January 1, 2008, all enterprises involved in processing prepared slices of Chinese crude drugs must comply with the GMP requirements.