新药临床试验申请监管体系的国际比较与启示
收稿日期: 2025-03-03
修回日期: 2025-06-09
录用日期: 2025-08-02
网络出版日期: 2025-08-06
基金资助
科技部“重大新药创制”科技重大专项（2017ZX09304005）
International Comparative Analysis and Insights on the Regulatory Systems for New Drug Clinical Trial Applications
Received date: 2025-03-03
Revised date: 2025-06-09
Accepted date: 2025-08-02
Online published: 2025-08-06
目的：探讨中、美、欧、澳、新、日各国家及地区对新药临床试验申请的监管模式与审查内容的共性与差异，分析我国在新药临床试验监管国际化过程中取得的进展及优化方向，为提升我国药品监管效率与国际竞争力提供借鉴。方法：通过文献研究、资料调研与比较分析，系统梳理中、美、欧、澳、新、日各国家及地区的新药临床试验申请监管体系，总结其特点并提出未来展望。结果：以上各国家及地区的新药临床试验申请监管体系在科学性和规范性上趋于一致，建立了以科学审评、伦理保障和质量保证为核心的监管科学技术标准，并具备未来实现监管互认的潜力。结论：我国新药临床试验申请监管体系已基本实现与国际标准接轨，未来建议进一步推动伦理审查互认，深化研究各方协作机制，并加强审评资源投入，以增强国际竞争力。
严钰茸
,
张菁
,
曹钰然
,
何金杰
,
曹国英
,
武晓捷
.
新药临床试验申请监管体系的国际比较与启示
Objective： To explore the commonalities and differences in the regulatory processes and review contents for new drug clinical trial applications in China， the United States， the European Union， Australia， New Zealand， and Japan， and to analyze China’s progress and optimization directions in new drug clinical trial regulation in the context of internationalization， providing insights to improve China’s drug regulatory efficiency and international competitiveness. Methods： Through literature review， data collection， and comparative analysis， the regulatory systems of new drug clinical trial applications in China， the United States， the Eurpean Union， Australia， New Zealand， and Japan were systematically reviewed， their characteristics were summarized， and prospects were discussed. Results： The findings indicate that the regulatory systems of new drug clinical trial application in these countries and regions are converging in terms of scientific rigor and standardization， with the establishment of regulatory science and technical standards centered on scientific review， ethical assurance， and quality control， showing potential for future regulatory mutual recognition. Conclusion： China’s new drug clinical trial application regulatory sysem has largely aligned with international standards， further efforts are recommended to promote mutual recognition of ethical reviews， deepen collaboration mechanisms among stakeholders， and enhance resource allocation for regulatory reviews to strengthen its international competitiveness.
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