
The EAEU medicines market
The final transition to the EAEU standards for medicines is planned for the end of 2025. By that time, the dossiers for all medicines must be brought into line with the requirements of the Union. And the primary registration of a medicinal product according to national requirements on the territory of the EAEU is no longer possible at all (except in cases of strategically important drugs, such as in the Republic of Belarus).
It is worth noting that as of the end of July, 3,500 of the 11,000 registration certificates included in the state register of medicines of Russia, which is approximately 30%, were brought into compliance with the requirements of the Union. At the same time, most drugs are harmonized through the Russian Federation.
As for the EAEU register of medicines, there are more than 6,000 entries in it, while most of the drugs (about 80%) "entered" the EAEU market through the Russian Federation.
Other EAEU member states act as reference states mainly for medicines of their own production.
At the same time, there is an increasing tendency for medicines to enter other markets of the EAEU member states either as part of the recognition procedure (if the drugs have already been registered in certain EAEU states), or as part of the geographical expansion procedure (if the drugs enter the market of the EAEU countries where they have not previously been applied).
This is primarily due to the fact that the EAEU countries mutually recognize the results of pharmaceutical inspections, preclinical and clinical trials of medicines conducted in accordance with the unified requirements of the EAEU.