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.
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.
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. Chinese Pharmaceutical Journal, 2020, 55(19): 1561-1563.
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.