Status Quo of Drug Supervision in China

V. International Exchanges and Cooperation in Drug Safety

The Chinese government attaches great importance to and actively participates in various international drug safety activities, constantly broadens the channels and scope of foreign exchanges and cooperation, and earnestly fulfils its international duties, playing a positive role in safeguarding the safe use of drugs by consumers all over the world.

The Chinese drug administration department is energetically conducting exchanges and cooperation with foreign countries. China has signed cooperative agreements and memorandums with the drug regulatory authorities of the United States, Canada, France, the United Kingdom, EU, Italy, Australia, Cuba, Brazil, South Korea, Singapore and Thailand. In 2007 China signed a cooperation agreement with the US on drugs and medical devices, setting up mechanism of meetings between senior officials of the drug regulatory authorities of the two countries, and enhancing the supervision over the export and import of raw pharmaceutical materials (active pharmaceutical ingredients), thus providing an effective solution to the quality safety problem of export and import drugs and medical devices. China has made significant achievements in cooperation regarding traditional medicine with the United States, Canada, France, EU, Italy, Australia, Singapore and Thailand. Twenty Chinese crude drugs are adopted in the French list of medicinal plants, seven standards for Chinese crude drugs are adopted in the French pharmacopoeia, and four standards in the European pharmacopoeia through French recommendation. China and Japan jointly conduct the projects of the Sino-Japanese Friendship Center for Safety Evaluation of Drugs, and has established the National Center for Safety Evaluation of Drugs (NCSED), which basically meets the GLP requirements. Through the mechanism of joint commissions on economy and trade, China, the United Kingdom and Russia work cooperatively in drug imports and exports, and market access, promoting the normal development of the pharmaceutical trade.

China actively consolidates and develops its cooperation with the World Health Organization (WHO). China has successively executed the planned programs of the WHO covering the establishment of a system of essential medicines, combating the production and sale of counterfeit drugs, supervision of the use of antibiotics, improvement of access to medicines, comparative studies of drug regulations, safety of biological products, and access to information about drugs, as well as programs such as ADR monitoring, GCP and training of GMP inspectors for vaccines. China energetically participates in various important drug-related activities organized by the WHO, conducting extensive exchanges in the field of quality standards. China is active in hosting various international conventions. Through exchanges and cooperation with international organizations, it is able to further understand the current situation and trend of international drug administration, and to draw advanced experience, playing a positive role in improving the level of supervision and involving in international coordination in this respect.

In recent years China has launched increasing non-governmental exchanges and cooperation initiatives concerning drugs with other countries and regions. China's National Institute for the Control of Pharmaceutical and Biological Products and the Chinese Pharmacopoeia Commission have signed cooperation memorandums with the United States Pharmacopoeia (USP) and European Pharmacopoeia Commission (EPC), and signed a cooperation agreement with the UK's National Institute for Biological Standards and Control (NIBSC). The China Center for International Pharmaceutical Exchanges has established relations of cooperation with non-governmental groups and academic organizations from over 20 countries and regions. The China Pharmaceutical Association sends a delegation to attend the World Pharmaceutical Conference every year, and has established regular contacts with the American Society of Health-System Pharmacists (ASHP) and the Pharmaceutical Society of Japan (PSJ). China also energetically conducts exchanges with international pharmaceutical associations, societies and chambers of commerce in China, promoting extensive exchanges and cooperation between Chinese and foreign pharmaceutical circles. The China Chamber of Commerce for Import & Export of Medicines & Health Products has established cooperative relations with government bodies and pharmaceutical organizations from more than 20 countries and regions, including Japan, Republic of Korea and Russia, accelerating the protection of intellectual property rights in drugs and initiating the self-disciplined management of drug import and export enterprises.

Through efforts over many years, China has made remarkable progress in the supervision over drug safety. However, as the largest developing country in the world, China is still facing many difficulties and problems in this regard. More efforts need to be made to adjust the structure of the drug industry, improve the mode of production, reform the drug-safety administration system, and improve the research and development and renovation capabilities of the drug industry, as well as the prevention and management of drug risks. The Chinese government determines to thoroughly implement the scientific outlook on development, to stick to a people-oriented approach, further strengthen drug safety work, and to speed up the improvement of the level of the health of the people. China will continue to strengthen international exchanges and cooperation in pharmaceutical field, and join hands with other countries to provide safe and effective and quality controllable drugs to consumers of various countries, making further contributions to the cause of human health.