REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot161510.32687/1561-5936-2023-27-2-150-160Original ArticleIssues of adapting the text of the European Union rules of good manufacturing practice to pharmaceutical market of the Eurasian Economic UnionMeshkovskiyAndrei P.001PyatigorskayaNathalia V.002BelyaevVasiliy V.003BeregovykhValery V.004AladyshevaZhanna I.005BrkichGalina E.006NikolenkoNatalia S.007FilippovaOlga V.008GreiboSergey V.009NesterkinaEkaterina I.010LosevaSofia A.011MarshalovaMarina M.012EremeevSergey A.013I. M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia15122023215016010102025Copyright © 2023,2023Full transition to the single pharmaceutical market of the Eurasian Economic Union (EAEU) should be completed in 2025. Currently, the development of missing regulatory and methodological materials for regulating the circulation of medicines in the region, including the Current Good Manufacturing Practice (GMP) Regulations, continues. These Rules were conceived as an adapted translation of the relevant EU Guidelines, but there are certain differences from the Western European prototype. The article discusses significant differences affecting four aspects of GMP: the procedure for release of pharmaceutical substances, the mechanism of batch certification, the role of GMP in quality control of imported medicines and quality assurance in the production process of drugs for clinical trials. According to the Eurasian GMP Rules, Qualified Person is responsible for batch release of active pharmaceutical ingredients, while in the EU countries and in many other states this procedure is responsibility of the Quality Service. The decision of the qualified person on the batch release of medicines is documented with Certificate of Eurasian GMP compliance. However, in EU countries, the decision to release a batch is documented in the form of a record in a register or other database. According to the EU rules, the release of imported batches of finished pharmaceutical products into circulation is carried out in the recipient country, after drug products are moved across the EUs external customs borders. In the EAEU countries, the batches of imported drugs are controlled, certified and released in the country of production. The EAEU GMP Rules for the production of drugs for clinical trials, including the main text of the Rules and Appendix No. 13, contain a number of errors in translation and interpretation of the original EU standard. For example, instead of Clinical Trials Authorization of the drug, there is a link to the Clinical Trial Protocol. The original term «product specification file» is translated as «investigational drug dossier». The authors see the most relevant direction in the course of revising the previously adopted regulatory and methodological documents of the common Eurasian drug market in determining the role of a qualified person in the batch release of active pharmaceutical ingredients and setting the procedure for certification of batches of imported finished medicinal products. Also noteworthy is the task of updating the GMP requirements for the production of drugs studied in clinical trials.medicinal productGood Manufacturing PracticesGMPqualified personbatch certificationinvestigational medicinal productinvestigational medicinal product dossierлекарственный препаратправила надлежащей производственной практикиGMPУполномоченное лицосертификация серийисследуемый лекарственный препаратдосье исследуемого лекарственного препарата1.Gouveia B. G., Rijo P., Gonçalo T. S., Reis C. P. Good Manufacturing Practices for Medicinal Products for Human Use. J. Pharm. Bioallied Sci. 2015;7(2):87—96. doi: 10.4103/0975-7406.1544242.Role and functions of Qualified Person. In: S. N. Bykovske (ed.) Comments on the European Union Guidelines on Good Manufacturing Practice of Medicinal Products for Human Use and Veterinary Use. Moscow; 2014. (In Russ.)3.Rozhdestvenskij D. The role and place of the Qualified person in the system of good distribution practice. Collection of articles “GDP REVIEW”: material of the II International Conference SCM Pharm: drug logistics. Moscow; 2020. (In Russ.)4.Thayer A. Europe adopts GMP regulations. Chemical & Engineering News. 2006; 84:29—33. doi: 10.1021/cen-v084n007.p0295.Stoimenova A. H., Kirilov B. J., Gueorguiev S. R. et al. Good Manufacturing Practice for medicinal products in Bulgaria: an analysis of regulatory inspection findings. Folia Med. (Plovdiv). 2020;62(1):165—171. doi: 10.3897/folmed.62.e498026.Shafiei N., Ford J. L., Morecroft C. W. et al. Transformation in the pharmaceutical industry — a systematic review of the literature. PDA J. Pharm. Sci. Technol. 2013;67(2):105—122. doi: 10.5731/pdajpst.2013.009047.Gérard C., Tall M. L., Reymond E. B. et al. Implication pharmaceutique dans le cadre d'essais cliniques institutionnels : évaluation de la qualité des opérations de mise sous forme pharmaceutique. Ann. Pharm. Fr. 2015;73(3):197—214. doi: 10.1016/j.pharma.2014.11.0048.Tatem L., Audrey C., Kim E., Sylvie Hansel-Esteller. Analysis of the compliance of clinical trials department preparation practices to the new good manufacturing practices (GMP). Pharm. World Sci. 2009;31:315. doi: 10.1007/s11096-008-9274-89.Beregovykh V. V., Meshkovsky A. P. Regulation of pharmaceutical production. Product quality assurance. Moscow; 2001. (In Russ.)10.Vasil'ev A.N., Reutskaja L. A., Bajdullaeva Sh.A. et al. Medicinal product as an object of regulation. Correlation of concepts and qualifying signs. Remedium. 2014;(11):57—67. (In Russ.)11.Meshkovsky A. Terms for technical regulations for medicinal products. Remedium. 2004;(9):68—77. (In Russ.)12.Mit’kina L.I., Ericheva A. K. Current requirements for information content and graphic design of a medicinal product package. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2019;2(9):108—117. (In Russ.)13.Haleem R. M., Salem M. Y., Fatahallah F. A., Abdelfattah L. E. Quality in the pharmaceutical industry — а literature review. Saudi Pharm. J. 2015;23(5):463—469. doi: 10.1016/j.jsps.2013.11.00414.Vogels H.-P. Quality surveillance in the supply chain of API: risks and challenges for the «qualified person». Die Pharmazeutische Industrie: Pharmind. 2015;77(6):815—825.15.Woodcock J. Reliable drug quality: an unresolved problem. PDA J. Pharm. Sci. Technol. 2012;66(3):270—272. doi: 10.5731/pdajpst.2012.0086816.Kieffer R. G. The changing role of quality assurance in the pharmaceutical industry. PDA J. Pharm. Sci. Technol. 2014;68(4):313—319. doi: 10.5731/pdajpst.2014.0098717.Born G., Dietrich R., Heimke-Brinck R. et al. GMP re-invented for clinical trials? Pharmazeutische Industrie. 2017;79:638—645.18.Del Parigi A. Industry funded clinical trials: bias and quality. Curr. Med. Res. Opin. 2012;28(1):23—25. doi: 10.1185/03007995.2011.62865119.Geyer A. R.C., Sousa V. D., Silveira D. Quality of medicines: deficiencies found by Brazilian Health Regulatory Agency (ANVISA) on good manufacturing practices international inspections. PLoS One. 2018;13(8):e0202084. doi: 10.1371/journal.pone.0202084