Latest Status in the Transition to Unified Pharmaceutical Registration in the Eurasian Economic Union

The Eurasian Economic Union (EAEU) has made great strides in harmonizing regulations and creating a common market for medicines and medical devices among its member countries. As representatives summed up during a recent video conference, major progress has been achieved from 2020-2024. However, some key challenges remain in fully implementing unified standards.

Shelf in a pharmacy with medicines

Highlights of Achievements of EAEU

Over the last several years, the EAEU has:

  • Adopted over 100 legal acts to enable supranational registration
  • Worked out all procedures for including pharmaceuticals in the EAEU register
  • Settled issues around bringing registration dossiers in line with EAEU requirements
  • Simplified the registration procedure itself

As Viktor Nazarenko, Minister in charge of the EEC’s Technical Regulation pointed out:

“Today we are no longer talking about creating a legal framework, but more about how to make sure that what we have adopted is observed in life.”

By the Numbers:

  • Over 4,500 pharmaceuticals now included in the unified EAEU register
  • 10,000+ applications still pending
  • 80% of applications from Russian manufacturers

Work Still Needed on Implementation

While procedures are in place, actual uptake of the supranational registration system has lagged among some members. Transition to the system is mandated by January 1, 2026.

As Nazarenko noted, attempts by countries to maintain their own registration systems create difficulties:

“The creation of a common market for medicines and medical devices is a very large area of regulation. It is divided into two parts. The first is to achieve a single regulatory system. The second stage is to balance supply and demand in order to develop production in the EAEU countries and cooperation between them.”

Moving EAEU Integration Forward

With the current EEC composition finishing up, leadership will transition to a team headed by a representative from Kazakhstan.

Key priorities going forward include:

  • Getting countries to fully adopt unified standards
  • Encouraging more applications and participation beyond Russia
  • Facilitating cooperation and balanced production across members
  • Ensuring barrier-free trade and no duplication of product checks

The EAEU still has work to do, but the groundwork has been laid for a more harmonized system for registering and trading medicines.

Get Your Medicines Registered by Delta Medical, the EAEU Experts

Leverage our in-depth knowledge and connections to swiftly register products under new unified EAEU rules.

At Delta Medical, we specialize in helping pharmaceutical companies navigate regulatory environments across the EAEU

With offices in Kazakhstan and connections throughout Eurasia, we are well positioned to assist with unified medicine registration and access to these growing markets even before 2026.

As the EAEU advances implementation of harmonized rules, it presents a strategic opportunity for companies looking to increase regional distribution and sales. Our team of experts can guide you through newly streamlined application procedures, requirements dossiers, and more. We have the relationships and experience across Eurasia to pave the way for bringing your medicines to patients in these countries.

Please contact Delta Medical to learn more about our registration and market access services tailored specifically for pharmaceutical brands looking to enter or expand in Kazakhstan, Russia, Belarus, Armenia or beyond. Our solutions can save you significant time and resources while leveraging the EAEU’s progress toward integration. Reach out today to get your medicine registered and sold across Eurasia!

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