China's new GMP Regulation effective since March 1, 2011

The State Food and Drug Administration of China (SFDA) published a revised version of the GMP regulation. This new version came into force just recently, on 1st March 2011

In a press release, the SFDA states: "Since its first promulgation in 1988, China's Good Manufacturing Practice for Pharmaceutical Products (GMP) has experienced two revised editions in 1992 and 1998. The new version of GMP consists of 14 chapters and 313 articles, with high increase of length compared with the 1998 revised edition. Borrowing advanced international experiences and in light of the actual conditions of China, under the principle of attaching equal importance to the "software and hardware", the new version of GMP follows the concepts of quality risk management and whole process control of drug manufacturing, attaches more importance to the scientific nature, instruction function and maneuverability, so as to consistent with the WHO GMP."

From March 1, 2011 all the newly built drug manufacturers and the newly built (reconstructed or extended) workshops of drug manufacturers will need to comply with the requirements of the new version of GMP. Already existing drug manufacturers will be granted a transition period. In a press conference on February 25, the SFDA explained that the production of blood products, vaccines, injections and other sterile pharmaceutical products in existing drug manufacturers will have to meet the requirements of the new version of GMP before December 31, 2013. All other manufacturers of pharmaceutical products will have to meet the requirements of the new version until December 31, 2015. According to the press release, drug manufacturers (workshops) who fail to meet the requirements of the new version of GMP won't be allowed to continue their drug production after the above deadlines.

Currently the revised GMP regulation is only available in Chinese language.

Source: SFDA Press Release and Press Conference

Learn more about this development at the 4th European GMP Conference. For the first time, a SFDA speaker will explain the new GMP version.

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