Research on the Qualification of Drug Centralized Procurement Declaration Subject Based on the Market Authorization Holder System

  • yang sun sun
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  • , 100055,

Received date: 2024-10-30

  Revised date: 2024-12-06

  Accepted date: 2025-11-15

Abstract

Abstract Objective: To explore the necessity and feasibility of Drug (Marketing Authorization Holder)MAH and the domestic legal entity designated by Oversea Drug MAH as the main declarer for centralized drug procurement after the revision of the Drug Administration Law. Method: By analyzing the current situation and existing problems of the main body of Centralized procurement of drugs, combined with the MAH, policy adjustment suggestions for drug centralized procurement declarer are proposed. Result: After the revision of the Drug Administration Law, Drug MAH have become the main legal body responsible for the quality of the entire life cycle of drugs. Drug manufacturer and Drug MAH have separated their roles, and there are still certain problems with drug manufacturer and other entities being the centralized procurement Declarer for drugs and assuming full process responsibility. Conclusion: It is recommended to Drug MAH and the domestic legal entity designated by Oversea Drug MAH as the Declarer for centralized drug procurement and assume full process responsibility, further improve the "Two invoice policy" policy, and pay attention to the new problems caused by Drug MAH(MAH) as the Declarer for centralized drug procurement.

Cite this article

yang sun sun . Research on the Qualification of Drug Centralized Procurement Declaration Subject Based on the Market Authorization Holder System[J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 0 : 0 . DOI: magtech.2024.10.30-00001

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