On February 2, 2023, Yunnan Longjin Careyou Pharmaceutical Co., a subsidiary of Kunming Longjin Pharmaceutical Co., LTD. (hereinafter referred to as Longjin Pharmaceutical), Ltd. (hereinafter referred to as Longjin Careyou) has obtained the "Drug Production License B" issued by the Drug Administration of Yunnan Province, indicating that Longjin Careyou, as a pharmaceutical research and development institution, can entrust the parent company with drug production without drug production workshop. Which has a drug production approval. The Marketing Authorization Holder (MAH) refers to the enterprise or drug development institution that obtains the drug registration certificate, namely the owner of the drug approval number. This production license is also the third drug production license B issued by the MAH system of Yunnan Province.
In the process of bidding for the drug production license, in addition to the unremitting efforts of all departments of Longjin Careyou, it has also been supported by the relevant departments of Longjin Pharmaceutical industry. Since the application was submitted in 2022, the department construction and quality system construction of marketing authorization holder have been continuously improved, the conditions for the landing of licensed varieties have been improved, the application materials have been prepared vigorously, the data review and on-site verification have been accepted by the provincial Food and Drug Administration, and the defect rectification has been carried out at the end of 2022, and the certificate has finally been issued by the Food and Drug Administration.
MAH system originated in Europe and the United States, it is a kind of separating the listed drug license and production license management system mode, generally refers to a drug drug technology research and development institutions, scientific research personnel, pharmaceutical production enterprises, such as the main body, through the proposed listing of drug licensing applications and drug license, approval documents and the drug quality mainly responsible throughout its life cycle of the system.
Since the 1980s, China has been implementing the management mode of combining drug marketing authorization and manufacturing authorization. Since the implementation of the new Drug Administration Law and the Drug Registration Management Measures in 2020, a series of relevant regulations and policies of the MAH system have been introduced one after another, and a new system centered on the drug marketing authorization holder system has gradually formed. On June 19, 2020, zhejiang and ze pharmaceutical technology co., LTD., won the national first the pharmaceutical production license, it marks the pharmaceutical research and development institutions can also have a drug approval.
MAH prior to the implementation of the system, the document of approval for drugs is a "bundled" registered model with production enterprise, the system implementation of the drug after authorisation from pharmaceutical production license. Pharmaceutical marketing authorisation holder shall have the right to own or entrust other pharmaceutical production enterprise, production of drugs and by the quality of production and sales of pharmaceutical major legal responsibility. The MAH system stimulates the research and development of pharmaceutical companies, so that more capable and skilled scientists can turn their own things into commodities and become valuable drugs for the people.