Provisions on Supervision and Administration of Drug Market Authorization Holder’s Implementation of Main Responsibility of Drug Quality and Safety
ISSUING AUTHORITY:
National Medical Products Administration
DATE OF ISSUANCE:
December 29, 2022
EFFECTIVE DATE:
March 1, 2023
The National Medical Products Administration (NMPA) promulgated the Provisions on Supervision and Administration of Drug Market Authorization Holder’s Implementation of Main Responsibility of Drug Quality and Safety (the “Provisions”) on December 29, 2022. The Provisions took effect as of March 1, 2023.
To fulfill the main responsibility of drug quality and safety by drug market authorization holder (“MAH”), the Provisions requires an MAH to establish working mechanisms and to perform specific management duties throughout the life cycle of drugs pursuant to existing drug regulatory laws and regulations. Specific requirements on the implementation of such responsibilities can be divided into the following 3 parts:
Firstly, the Provisions clarify the requirements for the establishment of management departments and personnel. The MAH should set up a management department with clear duties and responsibilities, an independent quality management department, and be equipped with managerial personnel compatible with the drug manufacturing and trading scale. The management personnel in key positions shall be full-time and shall include persons in charge of enterprise, manufacturing management, quality management, and quality. The enterprise person in charge is responsible for engaging or designating the person in charge of pharmacovigilance. It is mandatory for the above personnel should have working experience in relevant pharmaceutical fields.
Secondly, the Provisions further emphasize that an MAH shall establish a quality management system covering the entire process of drug production. To be specific, an MAH shall conduct an examination and approval of its suppliers of materials and packages, establish a post-market change control system and manufacturing release processes and standards. In the case of entrusted manufacturing of drugs, the MAH shall conduct review and approval of the manufacturing release processes and standards of the entrusted manufacturing enterprises, including drug test results and manufacturing release documents. Also, the Provisions require that the MAH Holder shall conduct an assessment on the quality assurance capability and risk management ability of the entrusted entity and sign a quality agreement and an entrusted manufacturing agreement with the entrusted entity. Additionally, the MAH shall establish and implement a drug traceability system, and provide traceability information as required to ensure the traceability of drugs.
Finally, the Provisions stipulate requirements for the quality management mechanism of the MAH, including without limitation investigation on deviation, review and approval of change items, establishment of annual reporting system, conducting regular retrospective analysis, conducting regular self-inspection or self-audit and establishment of training management system.
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