Countdown to new GMP certification, CFDA says time will not change

According to the news and newspaper summary of voice of China, more than 1300 aseptic drug manufacturers in China have passed the new version of GMP, which means only 20% of them have passed GMP certification The State Food and Drug Administration said recently that December 31 will be the "deadline" According to the new GMP, the production of blood products, vaccines, injections and other sterile drugs should meet the requirements of the new specification by the end of this year; five months later, the deadline will come, Li Guoqing, head of the pharmaceutical and Chemical Department of the State Food and drug administration, made it clear that the schedule will not change Li Guoqing: the standard will never be lowered, and the time will never be relaxed I hope that enterprises will attach great importance to this work, and do not misjudge the situation It is useless to find someone to talk with, and it is useless to cry The requirements for the transformation of the functions of the State Council involve the decentralization of certification authority, according to which some pharmaceutical enterprises hope to see the GMP certification work be decentralized to all provinces and relax the standards Li Guoqing said that only after completing this round of certification can we consider the issue of devolution of authority; Li Guoqing: if you fail to pass the certification on December 31, 2013, you must stop production on January 1, 2014, and you can pass the certification later This article is unswerving as far as CFDA is concerned.