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State Department Speech: GMP certification or will be canceled

2017-03-18

At the meeting, the CFDA audit inspection center, deputy director of the food and drug administration Sun Jinglin said, according to the requirements of the state council, on January 1, 2016, administration of all GMP certification authority down to the provincial bureau. GMP certification gradually and the integration of production licenses in the future, that is to say, GMP certification will be cancelled in the future.
On August 26, remember the CFDA article 2 of the official website published a story like this: the first phase of the national drug regulatory information system data standard management subsystem construction project bid announcement.
Look from the bidding documents at that time, the technical requirements, namely the country plans to achieve the goals mentioned: construction based on the monitoring and analysis platform of dispensing dose regulation (pilot), GLP regulation (pilot), GCP regulations (pilot), GMP regulation (pilot), drug regulatory analysis, data synchronization, and drug safety evaluation and other 7 subsystems.
In terms of GMP certification, choose better jilin 20 informationization foundation pharmaceutical production enterprise for pilot, irregular pharmaceutical production to off-site supervisions, without the need for GMP certification.
For GMP certification, in fact, it has been released country wind, wu zhen, deputy chief of the country are in a meeting made it clear that the future will cancel the GMP certification and country by the certification regulation, namely to drug firms shall be carried out in accordance with the GMP standard regulation. The pilot regulatory system is proposed in the tender documents, certification to promote action clearly state has been cancelled.

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