“Double classification” overview and reflection of drugs

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Affiliation: 1. Center for Food Evaluation, State Administration for Market Regulation/National Com-mittee on the Assessment of the Protected Traditional Chinese Medicinal Products, Beijing 100070, China 2. Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100022, China

Keywords: Drug Double classification Classification management

DOI: 10.19960/j.issn.1005-0698.202306012

Reference: Dong-Mei YU, Hong-Li YU.“Double classification” overview and reflection of drugs Dong-Mei[J].Yaowu Liuxingbingxue Zazhi,2023, 32(6): 698-701.DOI: 10.19960/j.issn.1005-0698.202306012.[Article in Chinese]  Copied

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Abstract

As a widely recognized and adopted management model internationally, drug classifi-cation management was officially implemented in China on January 1st, 2000. "Double Classification" management of drugs, as a special management mode in drug classification management, widely ex-isted at home and abroad. This article analyzed the situation of drug classification management in China, the USA, the U.K. and Japan, and proposed several considerations based on the current specific situation of drug classification management in China, with a view to providing reference for further improving the drug classification management system in China.

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References

1.国家药品监督管理局.处方药与非处方药分类管理办法（试行）(局令第10号) [EB/OL]. (1999-06-18)[2022-08-08]. https://www.nmpa.gov.cn/yaopin/ypfgwj/ypfgbmgzh/19990618010101883.html.

2.田春华，夏东胜.借鉴英国制度探讨我国处方药与非处方药“双跨”管理 [J]. 中国药物警戒, 2020, 17(12): 883-885. [Tian CH, Xia DS. "Double classification" management of prescription drugs and non-prescription drugs in China based on British system[J]. Chinese Journal of Pharmacovigilance, 2020, 17(12): 883-885.] DOI: 10.19803/j.1672-8629.2020.12.07.

3.国家药品监督管理局.关于第二批非处方药品进行审核登记工作的通知(国药监安[2002]228号) [EB/OL]. (2002-07-03) [2022-08-08]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/fgwj/gzwj/gzwjyp/20020703010101417.html.

4.国家药品监督管理局.关于公布第一批国家非处方(西药、中成药)目录的通知(国药管安[1999]198号) [EB/OL]. (2002-07-03) [2022-08-08]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/fgwj/gzwj/gzwjyp/19990611010101639.html.

5.胡骏, 颜建周, 邵蓉. 中国与美国非处方药管理体系的对比研究[J].中国新药杂志, 2019, 28(6): 641-645. [Hu J, Yan JZ, Shao R. Contrastive study of non-prescription drug management systems in China and United States[J]. Chinese Journal of New Drugs, 2019, 28(6): 641-645.]DOI: CNKI:SUN:ZXYZ.0.2019-06-001.

6.U.S. FDA. Drug application process for nonprescription drugs[EB/OL]. (2022-06-28) [2022-08-08]. https://www.fda.gov/drugs/types-applications/drug-application-process-nonprescription-drugs.

7.U.S. FDA. Prescription-to-nonprescription (Rx-to-OTC) switches[EB/OL]. (2022-06-28) [2022-08-08]. https://www.fda.gov/drugs/drug-application-process-nonprescription-drugs/prescription-nonprescription-rx-otc-switches.

8.GOV.UK. Medicines: reclassify your product[EB/OL]. (2022-08-03) [2022-08-08]. https://www.gov.uk/guidance/medicines-reclassify-your-product.

9.陈宁, 杨建红, 潘红波, 等. 美国和日本非处方药专论路径研究及对我国的启示[J]. 中国药事, 2020, 34(11): 1239-1246. [Chen N, Yang JH, Pan HB, et al. Study on the process of over-the-counter drugs in the United States and Japan and the implication for China[J]. Chinese Pharmaceutical Affairs, 2020, 34(11): 1239-1246.] DOI: 10.16153/j.1002-7777.2020.11.001.

10.Japanese Law Translation. 医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律[EB/OL].(1960-08-10) [2022-08-08]. https://www.japaneselawtranslation.go.jp/ja/laws/view/3213.

11.陈震, 邓万和, 田春华, 等. 国外处方药与非处方药转换管理制度的研究及对我国的启示[J]. 中国药事, 2020, 34(11): 1247-1254. [Chen Z, Deng WH, Tian CH, et al. Research on foreign Rx-to-OTC switch management system and its implication for China[J]. Chinese Pharmaceutical Affairs, 2020, 34(11): 1247-1254.] DOI: 10.16153/j.1002-7777.2020.11.002.

12.PMDA. Pharmaceuticals and medical devices safety information[EB/OL]. (1960-08-10) [2022-08-08]. https://www.jpma.or.jp/english/about/parj/eki4g600000078c0-att/2020.pdf.

13.沈梦娟. “双跨”药品管理机制研究[D]. 郑州: 郑州大学, 2020.

14.国家药品监督管理局. 关于开展处方药与非处方药转换评价工作的通知(国食药监安[2004]101号) [EB/OL]. (2004-04-07) [2022-08-08]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20040407010101754.html.

15.国家药品监督管理局.关于做好处方药转换为非处方药有关事宜的通知(食药监办注[2010]64号) [EB/OL]. (2010-06-30) [2022-08-08]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20100630120001753.html