China's first importation rule was initiated in 1988 requiring imported drugs to be registered. Provisions for Importation Registration were enacted in 1991 (5) and revised in 1999 (6). Provisions for Drug Administrative Protection (7) were published in January 1993, providing 7.5 years of administrative protection (marketing exclusivity) for drugs that were under patent protection from 1986 to 1992 in the United States and other major Western countries.
These regulations were designed to partly due to the international pressure to provide intellectual property protection, in accordance with the United States-China Memorandum of Understanding of January 1992.
In 1999, a new bureau responsible for new drug review was established. The State Pharmaceutical Administration of China, the Division of Drug Administration in the Ministry of Health, and the Division of Traditional Chinese Medicine in the Traditional Chinese Medication Administration Bureau were merged into the State Drug Administration. The new organization revised major provisions of drug regulation that had lagged behind the times and added new provisions and guidance related to new drugs, new biological products, and imported drugs. These regulations covered the drug registration procedure, new drug protection and technology transfer, Good Clinical Practice (GCP), and Good Laboratory Practice.
Importing drugs is an effective way to provide patients with access to new therapies as soon as possible. It also promotes the progress of the Chinese pharmaceutical industry. The current regulations state that sponsors of imported drugs should conduct clinical trials (or bioequivalence studies) in accordance with Chinese procedures and requirements (5). If an imported drug has not previously been marketed in China, the sponsor must conduct clinical trials in compliance with the provisions for new drug approval and GCPs. Usually, imported products receive a five-year imported drug license. The sponsor must submit an application to renew the license six months before the expiration date.
*Partly from The Regulation and Approval of New Drugs in China, Drug information Journal, Vol 37, 29-39,2004, RL, Deng, KI Katin
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