摘要
目的 2020年版《中国药典》中人用疫苗总论是对疫苗的总体要求,受到业内高度关注,为了使业内更好地理解和执行,本文对2020年版《中国药典 》人用疫苗总论的增修订进行介绍。方法 笔者介绍了2020年版《中国药典》中人用疫苗总论的增修订情况、增修订特点以及对下一步工作的建议等。结果 2020年版《中国药典》人用疫苗总论的质量标准更加完善,与国际标准更加协调并且可操作性得到提高。结论 《中国药典》将继续完善提高疫苗质量标准,规范疫苗生产、加强疫苗质量控制以及引导疫苗研发更加规范和严谨。
Abstract
OBJECTIVE The general monograph of vaccines for human use in the Chinese Pharmacopoeia (Ch.P) 2020 edition is the overall requirement for vaccines, which has attracted great attention from the industry. The introduction of the amendments to the general monograph of vaccines for human use will help the industry better understand and implement the 2020 edition of the Chinese Pharmacopoeia. METHODS This review introduces the updates and revisions in the general monograph of vaccines for human use in the Chinese Pharmacopoeia (Ch.P) 2020 edition. RESULTS The standards of the general monograph of vaccines for human use in the Chinese Pharmacopoeia (Ch.P) 2020 edition are more complete, more harmonized with international standards, and operability improved. CONCLUSION The Chinese Pharmacopoeia will continue to improve vaccine standards, regulate vaccine production, strengthen vaccine quality control, and guide vaccine research to be more standardized and rigorous.
关键词
中国药典 /
疫苗 /
质量标准
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Key words
Chinese Pharmacopoeia /
vaccine /
quality standard
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王晓娟, 曹琰, 赵雄, 郭中平.
2020年版《中国药典》三部人用疫苗总论增修订概况及建议[J]. 中国药学杂志, 2020, 55(19): 1561-1563 https://doi.org/10.11669/cpj.2020.19.001
WANG Xiao-juan, CAO Yan, ZHAO Xiong, GUO Zhong-ping.
Revisions and Suggestions for General Monograph of Vaccines for Human Use in Chinese Pharmacopoeia 2020 Edition[J]. Chinese Pharmaceutical Journal, 2020, 55(19): 1561-1563 https://doi.org/10.11669/cpj.2020.19.001
中图分类号：
R917
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参考文献
[1] Ch.P(2020). Vol Ⅲ(中国药典2015年版.三部). 2015:31-36.
[2] EP 9.0 . 2017:695-698.
[3] The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Guideline for Elemental Impurities Q3D(R1) . ICH, 2019 . https://database.ich.org/sites/default/files/Q3D-R1EWG_Document_Step4_Guideline_2019_0322.pdf.
[4] Vaccine Administration Law of the People′s Republic of China. 2019, . http://www.npc.gov.cn/npc/c30834/201907/11447c85e05840b9b12c62b5b645fe9d.shtml.
[5] The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Quality of biotechnological products: stability testing of biotechnological/biological/biological products Q5C. ICH,1995, . https://database.ich.org/sites/default/files/Q5C%20Guideline.pdf.
[6] Food and drug administration. Revocation of general safety test regulations that are duplicative of requirements in biologics license applications. Fed Regist, 2015, 80 (127):37971-37974.
[7] EP 9.6 . 2018:5-9.
[8] World Health Organisation. Main outcomes of the meeting of the WHO Expert Committee on Biological Standardization held from 29 October to 2 November 2018. WHO,2018. https://www.who.int/biologicals/expert_committee/ECBS_Executive_Summary_final_20_NOV_2018.IK.pdf?ua=1.
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