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National Drug Administration (2021) No.
31
The Drug Administration of all provinces, autonomous regions, and municipalities directly under the Central Government, and the Drug Administration of Xinjiang Production and Construction Corps:
In order to implement the "Drug Administration Law" and "Vaccine Administration Law", further standardize drug inspection behavior, and promote drug supervision work to adapt to the new situation as soon as possible, the State Drug Administration has organized and formulated the "Drug Inspection Management Measures (Trial)" (hereinafter referred to as the "Measures" ), is hereby issued.
The relevant matters are hereby notified as follows:
1.
All provincial drug supervision and administration departments shall, in accordance with the requirements of these Measures, and in light of the actual conditions of their respective administrative regions, formulate implementation rules, refine work requirements, organize inspections of drug production, operation and use, and continue to strengthen supervision and management.
2.
Each provincial-level drug regulatory authority shall urge drug marketing license holders in their respective administrative regions to establish and improve drug quality assurance systems, strengthen drug quality management and risk prevention and control capabilities, and ensure the continued legal compliance of drug production and operation, and Perform the main responsibility for drug quality.
3.
The "Measures" set out general regulations for the inspection of vaccines and blood products.
4.
The "Measures" shall come into force on the date of promulgation.
State Food and Drug Administration
May 24, 2021
annex:
Measures for the Administration of Drug Inspection (Trial).
doc
National Drug Administration (2021) No.
31
The Drug Administration of all provinces, autonomous regions, and municipalities directly under the Central Government, and the Drug Administration of Xinjiang Production and Construction Corps:
In order to implement the "Drug Administration Law" and "Vaccine Administration Law", further standardize drug inspection behavior, and promote drug supervision work to adapt to the new situation as soon as possible, the State Drug Administration has organized and formulated the "Drug Inspection Management Measures (Trial)" (hereinafter referred to as the "Measures" ), is hereby issued.
The relevant matters are hereby notified as follows:
1.
All provincial drug supervision and administration departments shall, in accordance with the requirements of these Measures, and in light of the actual conditions of their respective administrative regions, formulate implementation rules, refine work requirements, organize inspections of drug production, operation and use, and continue to strengthen supervision and management.
Perform territorial supervision responsibilities.
2.
Each provincial-level drug regulatory authority shall urge drug marketing license holders in their respective administrative regions to establish and improve drug quality assurance systems, strengthen drug quality management and risk prevention and control capabilities, and ensure the continued legal compliance of drug production and operation, and Perform the main responsibility for drug quality.
3.
The "Measures" set out general regulations for the inspection of vaccines and blood products.
If there are special regulations for the inspection of such drugs, the regulations shall be followed.
4.
The "Measures" shall come into force on the date of promulgation.
The former State Food and Drug Administration promulgated on April 24, 2003, the "Administrative Measures for the Certification of Pharmaceutical Business Quality Management Practices" and the "Administrative Measures on the Certification of Pharmaceutical Manufacturing Quality Management Practices" promulgated on August 2, 2011, were repealed at the same time.
State Food and Drug Administration
May 24, 2021
annex:
Measures for the Administration of Drug Inspection (Trial).
doc
