我国儿童用药临床试验期间药物警戒监管体系现状及思考

doi:10.19803/j.1672-8629.20220535

摘要/Abstract

摘要： 目的总结我国儿童用药临床试验期间药物警戒监管体系现状与不足,以期为进一步提升我国儿童用药临床试验期间药物警戒监管工作能力提供参考。方法采用理论研究与比较分析法,阐述了我国临床试验期间药物警戒法规现状,总结了针对儿童用药临床试验期间药物警戒法规制定的必要性,对比了儿童用药与成人用药安全性报告审核思维的差异,对监管提出建议。结果我国现有临床试验期间药物警戒法规多为针对整体人群,缺乏儿童用药相关法规。儿童用药临床试验期间安全性报告审核思维与成人报告差异较大,应当在制定审核标准时予以考虑。结论我国现有儿童用药临床试验期间药物警戒监管工作需进一步加强。

关键词: 儿童, 儿童受试者, 药物警戒, 临床试验, 新药研发, 伦理委员会, 药品不良反应

Abstract: Objective To summarize the current status of pharmacovigilance regulatory system during clinical trials of the pediatric drug in China, in order to provide reference for further improving of the pharmacovigilance regulatory capacity during the clinical trials of pediatric drug in China. Methods Theoretical analysis and comparative analysis were used to summarize the current status of pharmacovigilance regulations during clinical trials in China, compare the differences of drug safety reports review strategies between children and adults, and provide suggestions for the regulatory authority. Results Most of the current pharmacovigilance regulations during clinical trials in China are aimed at the overall population, and there are no regulations related to pediatric drug. There are significant differences of the drug safety reports review strategies between children and adults, and should be considered when developing review standards. Conclusion The pharmacovigilance regulatory system during clinical trials needs to be further refined for the pediatric drug.

Key words: pediatric, children subjects, pharmacovigilance, clinical trial, new drug development, ethics committee, adverse drug reactions

中图分类号:

R954

刘文东, 崔欢欢, 王晓晗, 苏娴, 王海学. 我国儿童用药临床试验期间药物警戒监管体系现状及思考[J]. 中国药物警戒, 2023, 20(9): 1002-1006.

LIU Wendong, CUI Huanhuan, WANG Xiaohan, SU Xian, WANG Haixue. Status and thinking of Parmacovigilance regulatory system during clinical trials of the pediatric drug in China[J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 1002-1006.

参考文献

[1] LIANG Q. Lack of motivation in clinical trials of the pediatric drug[N]. Economic Information Daily(经济参考报), 2021-08-25(005).
[2] YUAN LJ, WANG LQ, WANG XY, et al.The role and consideration of accelerated approval process in pediatric drug registration system[J]. Chinese Journal of Pharmaceuticals(中国医药工业杂志), 2022, 53(11): 1529-1538.
[3] LUO N. Review and approval of the pediatric drug are accelerated[N]. China Pharmaceutical News(中国医药报), 2023-01-17(001).
[4] Center for Drug Evaluation, National Medical Products Administration. The Annual Report on Progress of Clinical Trials for New Drug Registration in China (2021)[EB/OL]. (2022-06-07)[2023-03-16]. https://www.cde.org.cn/main/news/viewInfoCommon/1839a2c931e1ed43eb4cc7049e189cb0.
[5] Center for Drug Evaluation, National Medical Products Administration. The Annual Report on Progress of Clinical Trials for New Drug Registration in China (2020)[EB/OL]. (2021-11-10)[2023-03-16]. https://www.cde.org.cn/main/news/viewInfoCommon/d670723dd2f646722097b03cf005e052.
[6] PAN M.Analysis the Characteristic of the pediatric drug[J]. Journal of Practical Medical Techniques(实用医技杂志), 2013, 20(4): 403-404.
[7] NMPA.NMPA Issued the Announcement on Good Pharmacovigilance Practice (No.65 of2021)[EB/OL].(2021-05-07)[2023-06-01]. https://www.gov.cn/gongbao/content/2021/content_5629614.htm.
[8] Pharmaceutical Administration Law of the People's Republic of China[EB/OL]. (2019-08-26)[2023-06-01].https://www.gov.cn/xinwen/2019-08/26/content_5424780.htm.
[9] Vaccine Administration Law of the People's Republic of China[EB/OL]. (2019-06-29)[2023-06-01].http://www.npc.gov.cn/npc/c30834/201907/11447c85e05840b9b12c62b5b645fe9d.shtml.
[10] NMPA.NMPA publicly solicits opinions on the Implementation Regulations of Pharmaceutical Administration Law of the People's Republic of China[EB/OL]. (2022-05-09)[2023-06-01].https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjyp/20220509222233134.html.
[11] State Administration for Market Regulation.Provisions for Drug Registration[EB/OL]. (2020-01-22)[2023-06-01].https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_3275cb2a929d4c34ac8c0421b2a9c257.html.
[12] National Medical Products Administration, National Health Commission. NMPA and NHC Issued the Announcement on Good Clinical Practice (No.57 of2020)[EB/OL]. (2020-04-23)[2023-06-01]. https://www.gov.cn/gongbao/content/2020/content_5525106.htm.
[13] NMPA.NMPA Issued the Announcement on Good Pharmacovigilance Practice (No.65 of2021)[EB/OL].(2021-05-07)[2023-06-01]. https://www.gov.cn/gongbao/content/2021/content_5629614.htm.
[14] Center for Drug Evaluation, National Medical Products Administration. speed up the review and approval for the pediatric drug[EB/OL]. (2023-01-17)[2023-06-01].https://www.cde.org.cn/main/news/viewInfoCommon/0fa129a8ad32929943ac11ef43895930.
[15] National Medical Products Administration, National Health Commission. NMPA and NHC Issued the Announcement on Good Clinical Practice (No.57 of2020)[EB/OL]. (2020-04-23)[2023-06-01]. https://www.gov.cn/gongbao/content/2020/content_5525106.htm.
[16] FENG HY, ZHOU LY, LI H, et al.Research III on Pharmacovigilance and Risk Control During Clinical Trials of New Drugs: On Regulatory Requirements for Individual Case Safety Reports in Clinical Trials of Drugs[J]. Chinese Pharmaceutical Affairs(中国药事), 2022, 36(6): 630-636.
[17] National Medical Products Administration, National Health Commission. NMPA and NHC Issued the Announcement on Good Clinical Practice (No.57 of2020)[EB/OL].(2020-04-23) [2023-06-01]. https://www.gov.cn/gongbao/content/2020/content_5525106.htm.
[18] Center for Drug Evaluation, National Medical Products Administration. CDE issued the Announcement on safety information evaluation and management practices during drug clinical trials (No.5 of2020) [EB/OL]. (2020-07-01)[2023-03-16]. https://www.cde.org.cn/main/news/viewInfoCommon/a1d42f512a341bc079ffb79df91f9cc7.
[19] CIOMS. Management of Safety Information from Clinical Trials(临床试验安全信息管理) [M]//WANG HX, PEI XJ, CHEN J. Tianjin: Tianjin Science and Technology Translation and Publishing Co., Ltd,2022.
[20] LI XX, TANG ZM, ZHOU J, et al.Limitations of the safety assessment in premarketing clinical trials of drugs and suggestions for improvement[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2020, 164(8): 465-470.
[21] FDA. Best Pharmaceuticals for Children Act[EB/OL]. (2018-09-25)[2023-06-01]. https://www.fda.gov/drugs/development-resources/best-pharmaceuticals-children-act-bpca.
[22] FDA. Pediatric Research Equity Act[EB/OL]. (2019-11-07)[2023-06-01]. https://www.fda.gov/drugs/development-resources/pediatric-research-equity-act-prea.
[23] The U.S. National Archives and Records Administration. 21 CFR Part 50 Subpart D -Additional Safeguards for Children in Clinical Investigations [EB/OL]. (2001-04-24) [2023-03-16]. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50/subpart-D.
[24] European Medicines Agency. Regulation (EC) No1901/2006 of the European Parliament and of the Council of 12 December 2006 on Medicinal Products for Paediatric Use and Amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/ 2004. [EB/OL]. (2006-12-27) [2023-03-16]. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32006R1901&qid=1661481204018&from=EN.
[25] European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations IV: Paediatric population [EB/OL]. (2018-11-08) [2023-03-16].https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-phar.macovigilance-practices-gvp-product-population-specific-considerations-iv_en-0.pdf.
[26] FDA. Process for Handling Referrals to FDA Under 21 CFR 50.54 - Additional Safeguards for Children in Clinical Investigations[EB/OL].[2023-03-16]. https://www.fda.gov/media/75222/download.