The market for foreign drug registration in the EAEU has entered a new phase. The transition periods in the Union’s countries are coming to an end, and manufacturers who managed to bring their dossiers into compliance with EAEU requirements in time have already secured their market access. Now businesses face new tasks: scaling their presence across all five markets and expanding into more remote jurisdictions. We spoke about how not to lose ground and how to take advantage of emerging windows of opportunity with Victoria Korotenko, Head of the Foreign Registration Department at the ANO National Scientific Center for Pharmacovigilance.
Victoria, would you say the situation regarding the transition periods in the EAEU countries has been settled? First come, first served?
Yes, that’s exactly how it can be put. The main wave of bringing dossiers into compliance with EAEU requirements has passed. Manufacturers who timely updated their dossiers have secured their position in the market. Those who delayed for any reason are now facing blocking measures: in a number of countries, national marketing authorizations that were not brought into compliance with EEC Decision No. 78 and not submitted for alignment by the end of December 2025 are already being annulled. The drugs will be withdrawn from circulation, and it will be impossible to restore positions without a full re-registration.
So, is the main task for players now not to “catch up,” but to scale up properly?
Absolutely. Those who already have an EAEU marketing authorization in the reference country (most often Russia) are moving to the next stage — expanding their geography through the mutual recognition procedure. This is a logical step: why limit yourself to one market when you can legally operate in all five member states of the Union?
There are two paths here. The first is the mutual recognition procedure, where after approval of changes in the reference country, you submit applications to other member states. The second is the decentralized procedure, if entry into all or part of the markets is planned simultaneously.
What is the main risk here?
The risk is that regulators in different countries, even within the Union, may request conflicting information. A situation arises where one regulator requires additional justification, while another considers the same section of the dossier excessive. Manufacturers find themselves between a rock and a hard place: fulfilling the requests of all parties is technically difficult, and sometimes impossible without compromising the integrity of the dossier.
We see an urgent need for harmonization of comments in requests from regulators. If national authorities developed unified approaches to expertise and formulated their requirements more consistently, it would greatly simplify life for manufacturers and accelerate the introduction of drugs to the entire EAEU market.
Meanwhile, is the drug dossier submission system in the EAEU itself sufficiently well-established?
Sure, and this needs to be emphasized. Despite certain rough edges at the mutual recognition level, the drug registration system in the EAEU works clearly and predictably. The submission portal, dossier module requirements, examination procedures — all of this is already formed and understood by market participants.
For comparison: in the field of medical devices, harmonization is not progressing as rapidly, and many manufacturers prefer to register through national procedures. Against this backdrop, the EAEU pharmaceutical block is an example of stability and professionalism. For which we extend our great thanks to the regulators.
Moving on to the dietary supplement market—I understand that comes with its own set of rules?
Yes, and here an interesting contrast awaits us. Unlike medicines, for dietary supplements there is a procedure for obtaining a State Registration Certificate according to EAEU requirements, which is issued immediately for all five countries. This is a huge advantage: you get the document, and you work across the entire Union space without additional recognition procedures.
Pharmaceutical products are still far from this level of integration. They need to go through national phases in each country, which of course increases the time and cost of market entry. Therefore, we recommend that dietary supplement manufacturers use this window of opportunity while the rules remain unchanged.
Beyond the EAEU, where are manufacturers looking to expand?
We see a growing interest in the countries of Latin America and Vietnam. These are large markets with increasing demand for quality pharmaceutical products. The good news is that the requirements for registration dossiers there are largely harmonized with our standards. Therefore, with a quality EAEU dossier in hand, a manufacturer can scale up to these jurisdictions fairly quickly. We are also observing particularly active interest in Uzbekistan — a market that is currently developing rapidly and harmonizing its requirements with international norms.
So, putting it all together, what’s your advice for manufacturers on strategy for 2026?
Our advice to partners is always to think big picture and holistically. Piecemeal problem-solving — saving a Belarus registration today, figuring out Kazakhstan tomorrow — is the hard way. We help build a ‘single-window’ Eurasian strategy.
What does this mean in practice? First, conducting a thorough audit of all existing dossiers. Second, comprehensively updating the dossier to meet EAEU requirements: including the development of a package insert, conducting user testing, and updating all modules. Third, using the mutual recognition procedure to enter the other Union markets. And of course, in this process, you need to think more broadly right away: after establishing yourself in the EAEU, it is logical to enter the markets of Uzbekistan, Vietnam, and Latin American countries, using the already completed dossier.