Status Analysis on the Marketing Authorization Holder of China's Drugs

• Main Authors: Haishi Yu, Yingzhu Jiang, Weijun Zhou
• Format: Article
• Language: English
• Published: EDP Sciences 2020-01-01
• Series: E3S Web of Conferences
• Online Access: https://www.e3s-conferences.org/articles/e3sconf/pdf/2020/45/e3sconf_iceeb2020_04009.pdf

We analyze the basic situation of Marketing Authorization Holder (MAH) of drugs in China. Mathematical analysis was carried out on the approval time, product category, dosage form, listing permit holder and production unit of 3239 MAH of drugs in China as of July 31, 2019. We found the following results. The approval time for MAH of drugs was concentrated in 2015, mainly based on chemicals, and the dosage forms were mostly tablets and injections. Furthermore, the number of MAH of drugs varies greatly among different provinces, and the number of Hebei, Guangdong, and Jiangsu ranks in the top three. Thirdly, there are time differences, variety types and geographical differences in the MAH of drugs. This is the application for examination and approval after the full implementation of the MAH of drugs system, and the patent and intellectual property protection in the process of entrusted production technology transfer. The research provides reference for enterprise declaration and regulatory approval management after the full implementation of the MAH system in China.