Advanced Search

The State Food And Drug Administration On The Administrative Examination And Approval Of The Decision To Modify, Repeal, Retention Of Administrative Rules

Original Language Title: 国家食品药品监督管理局关于涉及行政审批的行政规章修改、废止、保留的决定

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$40 per month.
(June 30, 2004 national food drug supervision authority makes 8th, announced since July 1, 2004 up purposes) for guarantee administrative license method in food drug supervision management system of smooth implementation, according to State on implement implementation straddling People's Republic of China administrative license method of notification (country sent [2003]23,) and circular of the on implement implementation administrative license method work arrangements of notification (State sent [2003]99,) requirements, State food and Drug Administration will now involve administrative examination and approval of administrative regulations amended, repealed, and reservations to the public.
    Existing administrative regulations concerning administrative license provisions inconsistent with the administrative licensing law, in accordance with the provisions of the administrative permission law implementation. A, and involved administrative license, according to administrative license method for amendment of administrative regulations 9 items: (a) medical devices registered management approach (Amendment) since announced of day up purposes, national drug supervision authority makes 16th, medical devices registered management approach while abolition; (ii) medical devices production supervision management approach since announced of day up purposes, national drug supervision authority makes 18th, medical devices production enterprise supervision management approach while abolition; (three) Medical devices business enterprise license management approach since announced of day up purposes, national drug supervision authority makes 19th, medical devices business enterprise supervision management approach while abolition; (four) directly contact drug of packaging material and container management approach since announced of day up purposes, national drug supervision authority makes 21st, drug packaging with material, and container management approach (provisional) while abolition; (five) Internet drug information service management provides since announced of day up purposes, National drug supervision authority makes 26th, Internet drug information service management provisional provides while abolition; (six) medical devices manual, and label and packaging identifies management provides since announced of day up purposes, national drug supervision authority makes 30th, medical devices manual management provides while abolition; (seven) drug registered management approach since announced of day up purposes, national drug supervision authority makes 35th, drug registered management approach (pilot) while abolition; (eight)
    Lot release of biological products regulations come into force on the date of promulgation, State drug administration order 36th, the management of lot release of biological products (for trial implementation) abrogated; (IX) pharmaceutical manufacturing regulatory measures come into force on the date of promulgation, State Drug Administration, the 37th of the measures for the supervision and administration of drug production (for trial implementation) repealed simultaneously.
    II, and involved administrative license, according to administrative license method not need modified of administrative regulations 3 items: (a) national drug supervision authority makes 17th, medical devices new products approval provides (pilot); (ii) national food drug supervision authority, and People's Republic of China Customs makes 4th, drug imports management approach; (three) national food drug supervision authority makes 6th, drug business license management approach.
    Three, involving administrative licenses, need and other relevant regulations of the State Council published again after repeal or amend administrative regulations 2: (a) the State Drug Administration 12th in the management of ephedrine (for trial implementation), (ii) the 28th State drug administration regulations on the administration of caffeine.
    Four, involving administrative licenses, in accordance with the administrative licensing law requirements of the administrative regulations to be repealed on 1:11th State Drug Administration, the drug addiction treatment centres and drug regulation.
                                                  Five administrative rules, involving non-administrative approval, does not need to be modified on 1: State Drug Administration, the 25th of the implementing rules for the regulations on administrative protection of pharmaceuticals.