China: GMP Certification Required Beginning July 1, 2004

In response to concerns about the safety and effectiveness of pharmaceutical manufacturing in China, the State Food and Drug Administration (SFDA) will require Good Manufacturing Practice (GMP) authentication for all Chinese pharmaceutical manufacturers. The regulation goes into effect on July 1, 2004, and requires that all of the country’s 6,000 drug manufacturers comply with GMP regulations.

In 1998, China introduced but did not insist on GMP authentication, emphasizing a quality approach to manufacturing by promoting the production of safe and effective pharmaceuticals. However, concerns have arisen due to numerous medical accidents and legal issues resulting from unqualified manufacturers. Compliance with GMP regulations will allow Chinese drug makers to increase productivity, quality and safety through the modernization of manufacturing equipment and technology.

Approximately half of Chinese drug manufacturing companies have met Chinese GMP standards to date. An additional 1,000 companies are in the process of upgrading their technology, and thereby receive a six month grace period to meet the GMP requirements. If the minimum technology requirements are not met by December 31, 2004, the company will lose its license and be forced to close. Therefore, it is possible that approximately 20-30% of Chinese drug manufacturing companies could be closed down by the end of this year, due to non-compliance with GMP regulations.