13 items such as GMP certification and entrusted production are not under CFDA's control

Source: saibelan / situyangming June 11, 2015, the General Administration of food and Drug Administration issued the opinions on strengthening the in-process and in-process supervision over the cancellation and decentralization of administrative approval matters (hereinafter referred to as the opinions), and decentralized the rights of GMP certification, drug production and other entrusted production According to the opinion, in order to implement the notice of the State Council on regulating the administrative examination and approval of the departments under the State Council and the requirements of Premier Li Keqiang's speech at the teleconference on promoting the work of simplifying administration, delegating authority and combining function transformation, the general food and Drug Administration printed and distributed the opinion on strengthening the in-process and after the event supervision of the cancellation and delegating of administrative examination and approval At the same time of devolution of power, the opinions put forward higher requirements for supervision, which requires strengthening daily supervision and inspection We will implement daily regulatory responsibilities, and promote classified key regulatory, grid regulatory and intelligent regulatory We will strictly investigate and punish violations of the law We will intensify the investigation and punishment of key violations, strengthen data analysis such as complaints and reports, supervision and sampling, daily supervision and case investigation, strengthen the link between execution and punishment, and take multiple measures to crack down on illegal food and drug crimes According to the decision of the State Council, the General Administration of food and Drug Administration (hereinafter referred to as the General Administration) has 8 major items and 5 minor items in terms of the cancellation, decentralization and adjustment of administrative examination and approval 1、 Reduced major items of administrative examination and approval Including: (1) gradually decentralize the GMP certification to the provincial food and Drug Administration (hereinafter referred to as the Provincial Bureau); (2) decentralize the administrative license for entrusted production of drugs to the Provincial Bureau; (3) decentralize the approval of drug precursor chemicals in the first category to the Provincial Bureau; (4) ）To decentralize the examination and approval of drug precursor chemicals in the first category to the Provincial Bureau; (5) to decentralize the import license of protein assimilating agents and peptide hormones to the Provincial Bureau; (6) to decentralize the fixed-point production examination and approval of narcotic drugs, psychotropic drugs in the first category and psychotropic drugs in the second category to the Provincial Bureau; (7 ）Cancel the compulsory safety certification of some domestic class III medical devices; (8) adjust the qualification certification of medical device testing institutions to be implemented by AQSIQ and AQSIQ 2、 Reduced items of administrative examination and approval Including: (1) gradually delegate the administrative license for the first import of non special purpose cosmetics to the Provincial Bureau; (2) gradually delegate the administrative license for drug re registration to the Provincial Bureau; (3) gradually delegate the administrative license for supplementary applications that do not change the internal quality of drugs to the provincial Bureau; (4) ）To cancel the application for administrative license for the change of domestic class III medical devices without changing the internal quality of the products, and change it to record management; (5) ）The decentralized regional wholesale enterprises need to sell narcotic drugs and class I psychotropic drugs to the nearby medical institutions that have obtained the use qualification of narcotic drugs and class I psychotropic drugs within the administrative regions of other provinces, autonomous regions and municipalities directly under the central government to the Provincial Bureau for examination and approval.