China focuses on improving drug safety
Excerpt from the Pacific Bridge Medical (PBM) Asian Medical e-Newsletter (Volume 6, Number 8 November 2006)
On October 19, 2006, China launched a drug safety technology campaign. Recent drug-related incidents, such as the adverse reactions to antibiotic drug Xinfu manufactured in Anhui, have prompted the State Food and Drug Administration (SFDA) of China to take stringent steps towards more careful supervision of drug production. The SFDA, in conjunction with the Ministry of Science and Technology and the State Administration of Traditional Chinese Medicine, has initiated the campaign, which will focus on providing technological support for every step of the drug from manufacturing to patient.
With rapidly increasing drug development, intense competition, and steady improvements in drug manufacturing, monitoring and supervising drug companies has become a formidable task. New drugs, new materials, and new manufacturing processes have developed rapidly. With its drug safety campaign, the SFDA hopes to update its technology in monitoring drug companies. Counterfeit drug supervision has also become more difficult as counterfeiters have improved their manufacturing and production expertise. The SFDA plans to establish more drug safety research and review centers and streamline their supervision process with improved technology.
Other plans with improving drug safety overall are to improve post-marketing surveillance, develop monitoring and supervision of traditional Chinese medicine, implement pre-clinical trial safety checks, and develop standards for drug use and distribution. By establishing standards for all processes of drug production, the SFDA hopes to make the Chinese drug market more competitive with the international market.