Analysis and Suggestions on the Development of B-Certificate Holders of Drug Manufacturing Enterprises in China under the Marketing Authorization Holder System

The development of B-certificate holders for Chinese drug manufacturers under the marketing authorization holder (MAH) system highlights the value of system innovation and brings new opportunities for the development of the pharmaceutical industry. By analyzing the changes in the number of B-certificate holders, regional distribution, classification by formulation attributes, listed enterprises and patent applications from 2020 to March 2025, this paper reveals the rapid growth of B-certificate enterprises after the implementation of the MAH system and their regional and industrial characteristics. At the same time, it points out the problems existing in the responsibility awareness, regional development, management mechanism and innovation vitality of B-certificate enterprises. Based on this, it is recommended to strengthen the main responsibility of enterprises, promote the coordinated development of regions, improve the classification and management of preparations, and promote the coordinated development of enterprise scale and the enhancement of innovation vitality, so as to provide some reference for optimizing the MAH system and promoting the high-quality development of the pharmaceutical industry.