Announcement of china food and drug administration on matters related to the suspension of production and decentralization of sterile drug certification by enterprises that have not passed the certification of drug production quality management standards (revised in 2010) (No. 285 of 2015)


Release time:

2015-12-30

According to the relevant provisions of the implementation plan of the good manufacturing practice (revised in 2010) (hereinafter referred to as drug GMP), sterile drug manufacturers that have not passed the drug GMP certification have stopped production since January 1, 2014; other types of drug manufacturers that have not passed the drug GMP certification have all stopped production since January 1, 2016. According to the Decision of the State Council on the Cancellation and Decentralization of 50 Administrative Approval Items and Other Matters (Guo Fa [2013] No. 27), since January 1, 2016, the Food and Drug Administration of all provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the GMP certification of drug manufacturing enterprises, and the State Food and Drug Administration shall no longer accept applications for GMP certification. For certification applications that have been accepted, on-site inspections, audits and certification will continue to be organized. It is hereby announced. General Administration of Food and Drug Administration December 30, 2015