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SUN Chunmeng, CHEN Lei, LI Yanan, SONG Zonghua, YANG Zhaopeng, TU Jiasheng. Interpretation of the Guideline for Pharmaceutical Excipients of Animal Origin[J]. Journal of China Pharmaceutical University, 2022, 53(3): 376-382. DOI: 10.11665/j.issn.1000-5048.20220316
Citation: SUN Chunmeng, CHEN Lei, LI Yanan, SONG Zonghua, YANG Zhaopeng, TU Jiasheng. Interpretation of the Guideline for Pharmaceutical Excipients of Animal Origin[J]. Journal of China Pharmaceutical University, 2022, 53(3): 376-382. DOI: 10.11665/j.issn.1000-5048.20220316

Interpretation of the Guideline for Pharmaceutical Excipients of Animal Origin

Funds: This study was supported by the Chinese Pharmacopoeia Commission (No.ZG2017-5-03) and the Ministry of Science and Technology of China (No.2017ZX09101001006)
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  • Received Date: February 16, 2022
  • Revised Date: April 27, 2022
  • Pharmaceutical excipients of animal origin, an important part in pharmaceutical excipients, are widely used in pharmaceutical preparations.However, compared with the pharmaceutical excipients of other origins, pharmaceutical excipients of animal origin have more special requirements in many aspects, such as raw materials, production, quality control, storage, supervision, etc.Chinese Pharmacopoeia 2020 first included the Guideline for Pharmaceutical Excipients of Animal Origin, which introduces the basic ideas and technical requirements for the life cycle quality control of pharmaceutical excipients of animal origin based on the risk management concept.This article illustrates the specificity of the pharmaceutical excipients of animal origin, and interprets the main contents of this guideline in conjunction with relevant domestic and foreign regulations and technical documents, thereby providing comprehensive reference for the implementation of the guideline.
  • [1]
    . J China Pharm Univ(中国药科大学学报),2014,45(3):378-382.
    [2]
    Liu L,Yang Y. FDA''s risk management of quality-defects of drugs through reviewing heparin sodium event[J]. Chin J New Drugs(中国新药杂志),2011,20(20):1941-1945.
    [3]
    Yu QC,Guo T,Wang JZ. Hazard of contamination of Rotavirus vaccine with porcine Circovirus[J]. Chin J Biol(中国生物制品学杂志),2012,25(12):1719-1722.
    [4]
    Hong XX,Xu HY,Shang Y,et al. Brief introduction on Chinese Pharmacopoeia 2015 volume Ⅳ[J]. Drug Stand China(中国药品标准),2015,16(5):326-331.
    [5]
    Ma H,Huang L,Huang Y,et al. Application of the gelatin and albumin in biological pharmaceutical excipients[C]//Proceedings of 2014 Chinese Pharmceutical Conference and the 14th Chinese Pharmacist Week (2014年中国药学大会暨第十四届中国药师周论文集). Beijing:Chinese Pharmaceutical Association,2014:1-7.
    [6]
    National Medical Products Administration. Announcement on further strengthening the administration of bovine origin and its related drugs (关于进一步加强牛源性及其相关药品监督管理的公告) [EB/OL]. (2002-07-10)[2022-04-03]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20020710010101585.htmL.
    [7]
    Chinese Pharmacopoeia Commission. Chinese Pharmacopoeia:part 3 (中华人民共和国药典:三部)[S]. Beijing:China Medical Science Press,2020.
    [8]
    National Medical Products Administration. Guidelines for technical review of the animal origin medical device registration (动物源性医疗器械注册技术审查指导原则)[EB/OL]. (2018-01-05)[2022-04-03]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20180105112501619.htmL.
    [9]
    European Pharmacopoeia Commission. European Pharmacopoeia 9.0[S]. Strasbourg:European Directorate for Quality Medicines,2017.
    [10]
    National Medical Products Administration. Basic technical requirements for chemical injections and multi-component biochemical injections (化学药品注射剂和多组分生化药注射剂基本技术要求)[EB/OL]. (2018-01-10)[2022-04-03]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20080110120001739. html.
    [11]
    National Medical Products Administration. Provisions for drug registration (药品注册管理办法)[EB/OL]. (2020-03-30)[2022-04-03]. https://www.nmpa.gov.cn/zhuanti/ypzhcglbf/ypzhcglbfzhcwj/20200330180501220.html.
    [12]
    Xu XF,Chen SJ,Liu W,et al. Texture of gelatin gummy from different sources of gelatin[J]. China Food Addit(中国食品添加剂),2017(11):107-112.
    [13]
    Ma L,Wang H,Uratani J,et al. Comparison study of excipient regulations in China,the US and EU[J]. Chin J New Drugs(中国新药杂志),2012,21(22):2612-2622.
    [14]
    National Medical Products Administration. Requirements for the application materials of chemical drugs based on the new registration classification (trial)[化学药品新注册分类申报资料要求(试行)][EB/OL].(2016-05-04)[2022-04-03]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20160504175301774.html.
    [15]
    World Health Organization. WHO Tables on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies (WHO/EMP/QSM/2010.1)[EB/OL]. (2010-10-30)[2022-04-28]. https://www.who.int/publications/m/item/WHO-EMP-QSM-2010.1.
    [16]
    European Medicines Agency. Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMEA/410/01 Rev.3)[EB/OL]. (2011-06-29)[2022-04-03]. https://www.ema.europa.eu/en/documents/scientific-guideline/minimising-risk-transmitting-animal-spongiform-encephalopathy-agents-human-veterinary-medicinal_en.pdf.
    [17]
    The European Parliament and the Council of European Union. Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention,control and eradication of certain transmissible spongiform encephalopathies[EB/OL]. (2001-05-22)[2022-04-03]. https://www.legislation.gov.uk/eur/2001/999/contents#.
    [18]
    Center for Drug Evaluation,NMPA. Guidelines for technical methods and validation of removing and inactivating viruses in blood products (血液制品去除灭活病毒技术方法及验证指导原则) [EB/OL]. (2008-09-04)[2022-04-03]. https://www.cde.org.cn/zdyz/domesticinfopage?zdyzIdCODE=1df43aa707869a9c8bc11afe1ed48ff1.
    [19]
    National Medical Products Administration. NMPA announcement on matters related to further improvement of drug-related review,approval and administration (国家药监局关于进一步完善药品关联审评审批和监管工作有关事宜的公告) [EB/OL]. (2019-07-16)[2022-04-03]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20190716174501955.html.
    [20]
    Ministry of Agriculture and Rural Affairs of the People''s Republic of China,National Health Commission of the People''s Republic of China,and State Administration for Market Regulation.
    GB 31650-2019 National food safety standard:maximum residue limits for veterinary drugs in foods (食品安全国家标准:食品中兽药最大残留限量)
    [S]. Beijing:China Agriculture Press,2019.
    [21]
    Chinese Pharmacopoeia Commission. Chinese Pharmacopoeia:part 4 (中华人民共和国药典:四部)[S]. Beijing:China Medical Science Press,2020.
    [22]
    Liao B,Liu YM,Long HY,et al. Glycerol by different production processes and its production process evaluation[J]. Central South Pharm(中南药学),2014,12(12):1275-1276,1279.
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