The Good Manufacturing Practice for Pharmaceutical Products (2010 revised edition) (hereinafter referred to as the new version of GMP) was recently issued and will come into effect as of March 1, 2011, after five years of amendments and two rounds of public consultation.

　　Since its first promulgation in 1988, China’s Good Manufacturing Practice for Pharmaceutical Products (GMP) has experienced two revised editions respectively 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.

　　The new version of GMP will be effective from March 1, 2011. From that day, the newly built drug manufacturers and the newly built (reconstructed or extended) workshops of drug manufacturers shall comply with the requirements of the new version of GMP. The existing drug manufacturers will be granted a transition period of no more than five years and shall come up to the requirements of the new version of GMP by category and stage by stage in accordance with the product risk level.