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China to Strictly Enforce GMP for Pharmaceutical Manufacturers

February 3, 2004

Good Manufacturing Practice (GMP) standards were initially introduced in China in 1992. The standards provide basic rules and requirements pharmaceutical manufacturers in Mainland China must abide by in order to ensure the quality of drug products. In order to obtain GMP certification, companies are required to submit applications to the appropriate provincial or municipal drug authorities. Qualified assessors would then be sent to the manufacturing site and if the facilities pass inspection, a Chinese GMP certificate would be issued by the state administration and would be valid for five years.

However, GMP standards have not been strictly enforced in China. Many drug manufacturers operate in China without having GMP certification although they are by law required to hold this certification. China’s State Food and Drug Administration (SFDA) is planning to change this by announcing their plans to strictly enforce this requirement by next year. According to a circular that was recently published by the central government in early November 2003, companies utilizing raw materials or producing drugs not reaching GMP standards must halt production by July 1, 2004. However, pharmaceutical products produced up to June 30, 2004 can continue to be sold until their expiration dates when they must be withdrawn from the market.

Pharmaceutical manufacturers need to apply for GMP certification and register their manufacturing facilities with the provincial and municipal authorities. Those who fail to register by December 2004 may have their business and production licenses revoked.

Whether or not the SFDA’s increased initiative to strengthen pharmaceutical production quality in China will be a success is not yet known. The problem lies in the government’s ability to enforce the requirements. Experts in China predict that the worst offenders of GMP requirements will not be deterred by the new initiative and will continue to manufacture drugs illegally. Yang Shaogang, a lawyer in Shanghai dealing with high-profile cases involving the pharmaceutical industry, comments, “The disorder of the drugs market is due to governmental mismanagement. They must clean it up. The lives of thousands of people depend on it.”

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