| Issue |
E3S Web Conf.
Volume 185, 2020
2020 International Conference on Energy, Environment and Bioengineering (ICEEB 2020)
|
|
|---|---|---|
| Article Number | 04009 | |
| Number of page(s) | 5 | |
| Section | Chemical Engineering and Food Biotechnology | |
| DOI | https://doi.org/10.1051/e3sconf/202018504009 | |
| Published online | 01 September 2020 | |
Status Analysis on the Marketing Authorization Holder of China's Drugs
Center for Certification and Evaluation, Guangdong Drug Administration, Guangzhou, 510080
Corresponding author: 253152586@qq.com
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.
© The Authors, published by EDP Sciences, 2020
This is an Open Access article distributed under the terms of the Creative Commons Attribution License 4.0, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Current usage metrics show cumulative count of Article Views (full-text article views including HTML views, PDF and ePub downloads, according to the available data) and Abstracts Views on Vision4Press platform.
Data correspond to usage on the plateform after 2015. The current usage metrics is available 48-96 hours after online publication and is updated daily on week days.
Initial download of the metrics may take a while.