The EAEU Pharmacopoeia as a Harmonizing Basis for the Requirements for the Quality of Medicines in the EAEU and Beyond

Abstract

The author investigates a particular issue of drug compliance arising from the lack of broad harmonization between different pharmacopoeias around the world. The absence of customs barriers, the presence of a unified system of certification of goods, a single mark of conformity seems to be a sufficient legal basis for the development of a «Eurasian» pharmacopeia. It is important to emphasize the expanded perception of the scope of the EAEU pharmacopeia, according to which active pharmaceutical substances, excipients, drugs and other materials described in pharmacopeia articles are listed as objects of standardization of requirements, and both medicine and veterinary medicine are designated as a possible scope of their application. The EAEU has rightly adopted a course towards standardization and harmonization in a broader format of good pharmaceutical practices in the field of drug circulation. The content of pharmacopoeial monographs should also be taken into account when performing a patent search in the aspect of registration of inventions related to medicines. Taking into account the great potential of the EAEU in the context of medicines created on the territory of the EAEU and the Russian Federation used in the fight against coronavirus infection and other latest infections, diseases, the EAEU pharmacopoeia as an act of harmonizing requirements for the quality of medicines and the corresponding harmonization processes within the EAEU should be flexible, subject to rapid modernization and supplementation without any special obstacles at the national legal level from the EAEU member states. It is necessary to increase the extraterritorial potential for the use of the EAEU pharmacopoeia, in particular, as a tool for the admission of medicines to the EAEU pharmaceutical market and a mechanism for ensuring a high level of quality requirements for medicines in the world.