Full 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 EU's 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 product, Good Manufacturing Practices, GMP, qualified person, batch certification, investigational medicinal product, investigational medicinal product dossier.