Objective: To promote the sustainable development of the drug marketing authorization holder (MAH) system in China, and provide references for the high-quality development of the pharmaceutical industry. Methods: Relevant data on national drug applications and sampling from 2020 to 2022 since the implementation of the drug MAH system was systematically sorted out, and relevant data of on-site inspection from 150 drug manufacturing enterprises were randomly selected. Current situation and existing problems of drug MAH quality management were analyzed and the impact of the drug MAH system on key links such as drug innovation, review and approval, and quality supervision in China was summarized. Finally, the reference suggestions were proposed. Results and Conclusion: The drug MAH system has achieved initial results in stimulating the enthusiasm for drug innovation and optimizing the allocation of industry resources. It is recommended to continuously strengthen the main responsibility of the drug MAH, comprehensively improve drug regulatory capacity, improve the overall quality of inspectors, continue to deepen the reform of the drug review and approval system, and build a drug MAH system that conforms to China's national conditions.
Xu Dali, Zhang Wenxia
. Exploration on the Current Situation of Drug Regulation in China Since the Implementation of Marketing Authorization Holder System[J]. Chinese Pharmaceutical Affairs, 2023
, 37(8)
: 857
-863
.
DOI: 10.16153/j.1002-7777.2023.08.001
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