MAH's implementation of the list of main responsibilities for drug quality has come, and the key personnel of pharmaceutical companies are trembling

On November 30, 2022, in order to urge drug marketing authorization holders to implement the main responsibility for drug quality, further strengthen the quality supervision and management of the whole life cycle of drugs, further strengthen the main responsibility of MAH, and ensure the safety and effectiveness of drug use by the people, in accordance with the Drug Administration Law, the Epidemic Management Law, the Measures for the Supervision and Administration of Drug Production, the Good Manufacturing Practice and other relevant laws and regulations, the General Department of the State Food and Drug Administration issued the Provisions on the Supervision and Administration of Drug Quality Subject Responsibility by Drug Marketing Authorization Holders (Draft for Comments), the deadline for the draft is December 9
, 2022.
It is recommended that MAH conduct self-inspection in accordance with the list in advance, take precautions, prevent accidents, and effectively maintain the safety
of public medication.

1.
What is the scope of MAH key personnel?

1) The definition of key personnel in the current version of GMP in China in 2010: The key personnel of a pharmaceutical production enterprise shall be full-time personnel of the enterprise, at least including the person in charge of the enterprise, the person in charge of production management, the person in charge of quality management and the person in charge of quality authorization (Chapter 3 Institutions and Personnel Article 20).

2) Definition of key personnel in the Measures for the Supervision and Administration of Drug Production: On January 15, 2020, the "Measures for the Supervision and Administration of Drug Production" was deliberated and adopted by the first bureau meeting of the State Administration for Market Regulation in 2020, which came into force on July 1, 2020, clarifying that if the organizational structure, enterprise responsible person, production person in charge, quality responsible person and quality authorized person related to the quality management system of the drug marketing authorization holder or pharmaceutical manufacturer changes, it shall be within 30 days from the date of the change.
Complete the registration process
.
Within 15 days of the date of the change, the holder of the marketing authorization for the epidemic vaccine shall report to the drug administration department of the province, autonomous region or municipality directly under the Central Government where the epidemic vaccine is located the change of personnel in key positions such as the person in charge of production, the person in charge of quality, and the person authorized for quality (Article 45).

3) The definition of key personnel in the Provisions on the Implementation of the Supervision and Administration of Drug Quality Subject Responsibility by Drug Marketing Authorization Holders (Draft for Comments):

[Key personnel requirements]: The holder (including pharmaceutical production enterprises) shall be equipped with personnel in key positions such as the person in charge of the enterprise, the person in charge of production management (hereinafter referred to as the person in charge of production), the person in charge of quality management (hereinafter referred to as the person in charge of quality), the person in charge of quality authorization, and the person in charge of pharmacovigilance
.
The above key positions should be full-time personnel of the enterprise and meet the relevant requirements
of relevant quality management specifications.

[Definition of the person in charge of an enterprise]: The person in charge of an enterprise in these Provisions includes the legal representative and main responsible person
of the enterprise.

2.
What are the special requirements for key MAH personnel in the new regulations?

References

       [1] www.
nmpa.
gov.
cn