The Institutional Change and Suggestions of Pharmaceutical Marketing Authorization Holder in China

As a relatively comprehensive drug registration system internationally, the drug marketing authorization holder (MAH) system is one of the important systems of the newly revised Drug Administration Law in 2019. The MAH system runs through whole process of the drug development, production, operation and usage. Currently, the promulgation of supporting laws and regulations such as measures for the administration of drug registration, measures for the supervision and administration of drug production and measures for the administration of post marketing changes of drugs (for trial implementation) is conducive to the smooth implementation of MAH system and promotes the high-quality development of China’s pharmaceutical industry. This paper analyzes the exploration, trial implementation and final implementation of pharmaceutical marketing authorization holder (MAH) system in China, and puts forward some suggestions on stimulating the enthusiasm and creativity of scientific researchers and enterprises from the aspects of the main body and transfer mode of MAH system.