中国药品加速上市注册程序实施效果评价：2016-2024年监管审查的经验教训

IF 6.5 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Discovery Today Pub Date : 2025-04-10 DOI:10.1016/j.drudis.2025.104353

Yipeng Lan , Li Wang , Xiaofeng Lin , Yiqing Wu , Zhe Huang

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引用次数: 0

摘要

自2016年以来，中国实施了加速药品上市注册程序（ADMRPs），包括优先审评和批准（PRA）、有条件批准（CA）和突破性治疗药物（btd）。本研究分析了2016 - 2024年ADMRPs获批药品的特点，探讨了这些程序的实施效果。总体而言，922种药物通过5种admrp（或程序组合）获批上市：PRA（759,82.3%）、CA（12,1.3%）、CA + PRA（108,11.7%）、BTD + PRA（23,2.5%）和BTD + CA + PRA（20,2.2%）。通过不同程序批准的药物在药物属性和临床用途、临床试验设计、药物注册和营销方面存在很大差异。实施admrp在加速临床价值驱动型药物的开发和营销方面取得了优异的效果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Evaluation of the implementation effectiveness of accelerated drug marketing registration procedures in China: lessons from the 2016–2024 regulatory review

China has implemented accelerated drug marketing registration procedures (ADMRPs) since 2016, including priority review and approval (PRA), conditional approval (CA), and breakthrough therapy drugs (BTDs). This study analyzed the characteristics of drugs approved by ADMRPs from 2016 to 2024 and explored the implementation effectiveness of these procedures. Overall, 922 drugs were approved for marketing through five ADMRPs (or procedure combinations): PRA (759, 82.3%), CA (12, 1.3%), CA + PRA (108, 11.7%), BTD + PRA (23, 2.5%), and BTD + CA + PRA (20, 2.2%). Drugs approved through the different procedures differed widely in terms of drug attributes and clinical uses, clinical trial design, and drug registration and marketing. Implementing ADMRPs has demonstrated excellent results in accelerating the development and marketing of clinically value-driven drugs.

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来源期刊

Drug Discovery Today 医学-药学

CiteScore

14.80

自引率

2.70%

发文量

293

审稿时长

6 months

期刊介绍： Drug Discovery Today delivers informed and highly current reviews for the discovery community. The magazine addresses not only the rapid scientific developments in drug discovery associated technologies but also the management, commercial and regulatory issues that increasingly play a part in how R&D is planned, structured and executed. Features include comment by international experts, news and analysis of important developments, reviews of key scientific and strategic issues, overviews of recent progress in specific therapeutic areas and conference reports.