On May 28, the State Drug Administration issued the State Drug Administration's notice on the issuance of the "Measures for Drug Inspection and Management (Trial)". The measures consist of ten chapters and seventy articles, and are applicable to the inspection, investigation, evidence collection, disposal and other actions implemented by drug supervision and management departments on the production, operation and use of drugs listed in the People's Republic of China.
This "Measures" shall come into effect on the date of issuance.
The "Measures for Drug Operation Quality Management Standard Certification Management" issued by the former State Food and Drug Administration on April 24, 2003 and the "Measures for Drug Production Quality Management Standard Certification Management" issued on August 2, 2011 are abolished at the same time.
The following is the original text:
Drug Administrations of all provinces, autonomous regions, and municipalities directly under the Central Government, and Drug Administration of Xinjiang Production and Construction Corps:
In order to implement the "Drug Administration Law" and "Vaccine Administration Law", further standardize drug inspection behaviors, and promote drug supervision work to adapt to the new situation as soon as possible, the State Drug Administration has organized the formulation of the "Measures for Drug Inspection and Management (Trial)" (hereinafter referred to as the "Measures"), which are now issued. The relevant matters are hereby notified as follows:
1. All provincial-level drug supervision and administration departments shall formulate implementation rules and detailed work requirements in accordance with the requirements of this "Measures", combined with the actual situation of their administrative regions, organize inspections of drug production, operation and use, continuously strengthen supervision and administration, and earnestly perform local supervision responsibilities.
2. All provincial-level drug supervision and administration departments shall urge drug marketing license holders and others in their administrative regions to establish and improve drug quality assurance systems, strengthen drug quality management and risk prevention and control capabilities, ensure that drug production and operation are continuously legal and compliant, and earnestly perform the main responsibility for drug quality.
3. This "Measures" makes general provisions for inspections of vaccines and blood products. If there are special provisions for such drug inspections, they shall be followed.
4. This "Measures" shall come into force on the date of promulgation. The "Measures for the Administration of Certification of Good Operation Management Standards for Drugs" promulgated by the former State Food and Drug Administration on April 24, 2003 and the "Measures for the Administration of Certification of Good Production Management Standards for Drugs" promulgated on August 2, 2011 shall be repealed at the same time.
State Drug Administration
May 24, 2021
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