CHINESE JOURNAL OF MEDICINAL GUIDE >
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
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.
Yu-Rong YAN
,
Jing / Zhang
.
International Comparative Analysis and Insights on
the Regulatory Systems for New Drug Clinical Trial Applications
［1］ 国家药品监督管理局. 关于调整药物临床试验审评审批程序的公告（2018年第50号）［EB/OL］.（2018-07-27）［2025-01-26］.https：//www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ywlchshyjgrdgg/20180727172901286.html.
［2］ 国务院办公厅. 关于全面深化药品医疗器械监管改革促进医药产业高质量发展的意见（国办发〔2024〕53号）［EB/OL］.（2025-01-03）［2025-01-26］.https：//www.gov.cn/zhengce/zhengceku/202501/content_6996117.htm.
［3］ 国家药品监督管理局. 关于印发优化创新药临床试验审评审批试点工作方案的通知（国药监药注〔2024〕21号）［EB/OL］.（2024-07-31）［2025-01-26］.https：//www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20240731184417109.html.
［4］ FDA. Investigational New Drug （IND） Application［EB/OL］.（2024-11-18） ［2025-01-26］.https：//www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application.
［5］ 谭燕.美国FDA的新药临床试验申请和药品审批［J］.上海医药，2019，40（3）：64-66，77.
［6］ 周妍璇.FDA审评人员招聘放缓［EB/OL］.（2024-09-04）［2025-01-26］.http：//www.yyjjb.com.cn/yyjjb/202409/202409041657105710_19886.shtml.
［7］ 于冰，吴正宇，陈江鹏，等.美国药物临床试验及临床试验期间变更管理要求对我国完善监管体系的启示［J］.中国药事，2024，38（5）：508-515.
［8］ EMA. Transition period for clinical trial sponsors［EB/OL］.（2023-02-15）［2025-01-26］.https：//www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-regulation# transition-period-for-clinical-trial-sponsors-12919.
［9］ 王宏扬，陈江鹏，顾瑶华，等.欧盟药物临床试验及临床试验期间变更管理要求对我国完善监管体系的启示［J］.中国药事，2024，38（5）：499-507.
［10］ The European Parliament and of the Council. Regulation （EU） No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use， and repealing Directive 2001/20/EC ［EB/OL］.（2022-12-05）［2025-01-26］.https：//eur-lex.europa.eu/legal-content/EN/TXT/？uri=celex：32014R0536.
［11］ TGA. Australian clinical trial handbook ［EB/OL］.（2024-10-03）［2025-01-26］.https：//www.tga.gov.au/resources/guidance/conducting-clinical-trials-australia-using-unapproved-therapeutic-goods.
［12］ 昆翎.MelbourneChildren’s. MCTC048 SOP | Submitting and updating a CTN to the TGA［EB/OL］. （2023-03-21）［2025-07-04］.https：//metis.melbournechildrens.com/media/po3a1ba2/mctc048_sop_submitting-ctn-to-tga.pdf.
［13］ NHMRC. National Statement on Ethical Conduct in Human Research 2023［EB/OL］.（2024-01-01）［2025-01-26］.https：//www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2023
［14］ 薛桂琴.中、印、澳药物临床试验实施现状与监管对比研究［J］. 中国药事，2021，35（12）：1327-1334.
［15］ NSW Government.临床试验的未来澳大利亚，新南威尔士州［EB/OL］.（2019-08-15）［2025-01-26］.https：//www.medicalresearch.nsw.gov.au/app/uploads/2019/11/the-future-of-clinical-trials-nsw-simplified-chinese.pdf.
［16］ TGA. Classifying biologicals ［EB/OL］.（2024-09-24）［2025-01-26］.https：//www.tga.gov.au/resources/guidance/classifying-biologicals.
［17］ TGA. CTA Scheme ［EB/OL］.（2024-08-29）［2025-01-26］.https：//www.tga.gov.au/products/unapproved-therapeutic-goods/clinical-trials/clinical-trials# cta-scheme.
［18］ Medsafe. Guideline on the Regulation of Therapeutic Products in New Zealand［EB/OL］.（2018-11-30）［2025-01-26］.https：//www.medsafe.govt.nz/regulatory/Guideline/GRTPNZ/Part11.pdf.
［19］ 吴正宇，连志荣，王宏扬，等.日本药物临床试验及临床试验期间变更管理要求对我国完善监管体系的启示［J］.中国药事，2024，38（5）：489-498.
［20］ FDA. IND Applications for Clinical Investigations： Regulatory and Administrative Components［EB/OL］.（2022-03-07）［2025-01-26］.https：//www.fda.gov/drugs/investigational-new-drug-ind-application/ind-applications-clinical-investigations-regulatory-and-administrative-components.
［21］ The Royal Melbourne Hospital. Submit an ethics application for review［EB/OL］.（2023-01-24）［2025-01-26］.https：//www.thermh.org.au/research/office-for-research/ethics/submit-an-ethics-application-for-review.
［22］ Clinical trial notifications and scientific consultation system in Japan［EB/OL］.（2011-04-08）［2025-06-08］.https：//www.pmda.go.jp/files/000152326.pdf.
［23］ FDA. Chemistry， Manufacturing and Controls： Regulatory Considerations Through Clinical Development ［EB/OL］.（2023-12-06）［2025-06-09］.https：//www.fda.gov/media/175396/download.
［24］ 国家药品监督管理局药品审评中心.新药I期临床试验申请技术指南［EB/OL］.（2018-01-25）［2025-01-26］.https：//www.cde.org.cn/zdyz/domesticinfopage？zdyzIdCODE=741d8ec19a795e4656f768d43f097454./
| 〈 |
|
〉 |