CFDA: the new GMP certification standard will not be lowered, and the production license and GMP will be integrated

Source: the official of China food and Drug Administration (CFDA) introduced the recent work ideas of drug supervision at the 27th China Pharmaceutical Industry Development Summit Forum on May 14, 2015 He pointed out that the next step is to steadily implement the new version of GMP certification without lowering the standards and changing the time limit At the same time, a plan is being developed to integrate the drug production license with the new version of GMP certification GMP certificate is combined into one He pointed out that according to the requirements of the new GMP, non sterile drugs should meet the requirements of the new GMP before December 31, 2015 Up to now, half of the enterprises have passed the certification "We will continue to push forward in the next step, without lowering the standards or changing the time limit." He also said that the gradual implementation of drug production license and GMP certificate will be integrated "The specific scheme is being worked out, which may cancel GMP certificate, change GMP certification inspection into daily supervision and management, and carry out dynamic inspection on enterprises." In addition, the person pointed out that the quality certification of aseptic injections should be distributed to provincial units before the end of the year or gradually; the gap certification of traditional Chinese medicine should be cancelled, and CFDA will actively study the supervision and management methods of traditional Chinese medicine certification; the batch issuance of biological products is highly technical, and it is still in the charge of the State Administration of pharmaceutical supervision for the time being Finally, he said that he planned to integrate the three forces of comprehensive inspection, testing and inspection, hold regular risk assessment meetings and establish a risk assessment meeting system "The plan is being carried out."