欧亚经济联盟药品检查审查程序(审查)

Q3 Pharmacology, Toxicology and Pharmaceutics Drug Development and Registration Pub Date : 2021-08-28 DOI:10.33380/2305-2066-2021-10-3-138-146
A. P. Meshkovskiy, V. Beregovykh, V. N. Shestakov, N. Pyatigorskaya, Z. Aladysheva, N. Nikolenko, A. M. Pyatigorskiy, E. I. Nesterkina
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引用次数: 3

摘要

介绍文章讨论了药品制造商为遵守欧亚经济联盟(EAEU)良好生产规范(GMP)的要求而进行的药品检查程序的重大变化,这些变化与新冠肺炎大流行造成的限制有关。文本本文介绍了描述远程进行药品检查的主要国际准则,这是进一步更新EAEU法律中相关程序的基础。概述了疫情期间国外药品检验的实践。此外,还介绍了俄罗斯立法中控制和监督的监管方法的变化。结论这些数据表明,考虑到上述情况,有必要进一步趋同要求,即进行药品检查以符合GMP规则的要求,以协调俄罗斯监管文件、EAEU法律规范和国际标准之间的规范。这需要在利益攸关方的参与下开展对话。
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Procedure for Reviewing Pharmaceutical Inspections in the Eurasian Economic Union (Review)
Introduction. The article discusses significant changes in the procedure for pharmaceutical inspection of drug manufacturers for compliance with the requirements of the rules of good manufacturing practice (GMP) of the Eurasian Economic Union (EAEU), related to restrictions due to the COVID-19 pandemic.Text. The article presents the main international guidelines describing the remote conduct of pharmaceutical inspections, which is the basis for further updating the relevant procedures in the law of the EAEU. An overview of the foreign practice of pharmaceutical inspection during the pandemic is given. In addition, the changes in the Russian regulatory approaches to control and supervision in the Russian legislation are presented.Conclusion. These data give an idea that, with considering the above, there is a need for further convergence of the requirements, the practice of conducting pharmaceutical inspections for compliance with the requirements of GMP Rules in order to harmonize the norms between Russian regulatory documents, the norms of the EAEU law and international standards. This requires the development of a dialogue with the participation of stakeholders.
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来源期刊
Drug Development and Registration
Drug Development and Registration Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
1.20
自引率
0.00%
发文量
61
审稿时长
8 weeks
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