The Relationship between Various Entities in the Pharmaceutical Industry Chain - Production and MAH System

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The Relationship between Various Entities in the Pharmaceutical Industry Chain - Production and MAH System

Release time:

2021-03-10

The Drug Marketing Authorization Holder (Marketing Authorization Holder, MAH) system is closely related to the production of drugs. In the MAH system, the holder refers to the company or drug research and development institution that has obtained the drug registration certificate. The MAH can be a domestic company or an overseas company. , the system separates the production license from the marketing license, and the holder can produce drugs by itself, or entrust domestic and foreign drug manufacturers to produce. However, in principle, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, and pharmaceutical precursor chemicals are not allowed to be commissioned for production.

Before the trial implementation of the MAH system, my country implemented a management model that combined marketing authorization and production authorization, and only allowed drug manufacturers to produce the drug after obtaining the drug approval number and GMP certification. After the implementation of the MAH system, the scope of licensees has expanded, and research and development institutions can also become MAHs, thus changing the previous regulations that only manufacturers can hold drug batch numbers and cannot realize the entrusted production of drugs.

MAH is a kind of "full life cycle supervision". MAH is responsible for the entire life cycle of drugs: non-clinical research, clinical trials, production and operation, post-marketing research, adverse reaction monitoring, reporting and handling of drugs. Other units and individuals engaged in drug development, production, distribution, storage, transportation, use and other activities shall bear corresponding responsibilities according to law. The legal representative and main person in charge of MAH are fully responsible for the quality of medicines. MAH should establish a drug quality assurance system and assign specialized personnel to be independently responsible for drug quality management. MAH shall review the product quality and management system of entrusted drug manufacturers and drug distributors, and supervise their continuous quality assurance and control capabilities. If the MAH is an overseas enterprise, the corporate legal person designated by it in China shall perform the obligations of the MAH and bear joint and several liabilities with the MAH.

Evolution of the MAH system: This system is based on the "Decision on Authorizing the State Council to Carry out the Pilot Project of the Drug Marketing Authorization Holder System in Some Localities and Related Issues" on November 4, 2015, authorizing the State Council to implement the drug marketing authorization holder system in ten provinces, including Beijing, Tianjin, and Hebei. After the success of the pilot program of the license holder system for drug listing in municipalities directly under the Central Government, the new drug registration system established by the new Drug Administration Law in 2019. After the applicant obtains the drug registration certificate, it is the holder of the drug marketing authorization.

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