EAEU 2026: Common Pharmaceutical Market Launched – How Manufacturers Can Adapt to the New Reality

The EAEU pharmaceutical market worth $25 billion has officially launched. Learn how new registration rules, mutual recognition procedures, and extended transition measures affect manufacturers—and why Kazakhstan is emerging as a strategic gateway to Central Asia.

As of January 1, 2026, all new pharmaceutical products are registered exclusively under EAEU regulations. The transition period has concluded, and the market—encompassing 184 million consumers across five member states is valued at €22-24 billion ($25 billion).

In August 2025, the Concept for Development of the Common Pharmaceutical Market through 2030 was adopted. However, the launch of the system has revealed serious challenges: technical failures in information platforms, uneven readiness among member states, and a lack of mutual trust between regulators.

The cornerstone of integration is the Mutual Recognition Procedure (MRP), analogous to the European system. A reference member state conducts a comprehensive review and prepares an assessment report evaluating the safety, efficacy, and quality of the product. This report is then recognized by other member states (recognition states) without duplicate review.

Regulated Timelines:
• Registration in reference state: up to 210 working days
• Review in recognition state: not more than 40 working days from access to assessment report
• Complete harmonization procedure: not more than 100 working days

Reality on the Ground: Only Belarus demonstrate high readiness and compliance with established timelines. Kazakhstan, Armenia, and Kyrgyzstan face challenges stemming from weak technical infrastructure, incomplete digitalization of processes, and a shortage of qualified personnel. According to regulatory sources, recognition
states often conduct full reviews independently, lacking confidence in the reference state’s conclusions, resulting in duplicated procedures and extended timelines.

Marketing authorizations issued under national rules expired on December 31, 2025. However, transition measures are in place: companies that filed applications to bring their dossiers into compliance with EAEU requirements by the deadline receive extensions of national authorizations for the duration of the procedure (up to 3 years). Amendments made in September 2025 extended the deadline to December 31, 2027 for procedures adding recognition states.

Products manufactured before the expiration of the marketing authorization may continue to be marketed until the expiration of their shelf life.

In June 2025, the EEC Council adopted amendments to the Rules of Registration and Review of Medicines (Decision No. 34):
• Parallel conduct of the mutual recognition procedure and dossier correction procedures
• Streamlined requirements for manufacturer inspections within registration proceedings
• Optimized timelines to ensure continuity of patient supply

These measures reduce administrative burden and provide companies that missed the deadline with an opportunity to complete compliance without losing market access.

Kazakhstan is the second-largest pharmaceutical market in the EAEU by volume and serves as a strategic gateway not only to the union’s market but also to the rapidly growing markets of Central Asia.

Market Dynamics in Kazakhstan:
• Share of imported products: 85% by value, 68% by package count
• Share of pharmacy chains increased to 77% (Q1 2025), reflecting retail consolidation
• As of January 1, 2025, an electronic procurement portal for medical organizations is operational, enhancing transparency in tenders Kazakhstan as a Platform:
• Access to the EAEU through a simplified mutual recognition procedure
• Opportunity for export to rapidly growing markets in Uzbekistan, Kyrgyzstan, and Tajikistan
• According to Statista forecasts, the Central Asian pharmaceutical market will grow at a CAGR of 5.96% through 2030, reaching $540.77 million
• The broader Asian market demonstrates a CAGR of 3.7% (2024-2029), with Central Asia being one of the most dynamic segments

The Concept for Development of the Common Market through 2030 established priorities:
1. Updating GMP Requirements in line with ICH guidelines—a revised version is scheduled for implementation in 2026
2. Integrated Information Systems: a common registry of registered medicines, a unified pharmacovigilance system, and databases for inspections

However, according to the regulatory community, technical implementation and synchronization of digital platforms remain the system’s weakest link.

For Existing Registrations:
• If you missed the December 31, 2025 deadline, take advantage of the extension to December 31, 2027 for procedures adding recognition states
• Select a reference state based on readiness: Belarus is preferable
• Prepare your dossier in CTD format

For New Registrations:
• As of January 1, 2026, only EAEU rules apply
• Use the decentralized procedure for simultaneous submission to multiple countries, or the MRP for sequential geographic expansion
• Consider updated GMP requirements for 2026

The EAEU common pharmaceutical market is now operational, providing access to $25 billion and 184 million consumers. Despite technical challenges and uneven member state readiness, transition measures give manufacturers time to adapt. Simplified procedures and timeline extensions through 2027 enable companies to
complete dossier compliance without risking market loss.

Kazakhstan functions not only as a key EAEU market but also as a strategic gateway for penetration into the rapidly growing Central Asian markets with a combined population exceeding 75 million people.

InvestPharm a.s. provides comprehensive support for manufacturers entering EAEU and Central Asian markets:
• Preparation of regulatory dossiers in CTD format
• Selection of optimal registration strategy (national, decentralized, MRP)
• Coordination of procedures to bring dossiers into EAEU compliance
• Support for GMP inspections
• Logistics through our GDP-certified warehouse in Bratislava
• Pharmacovigilance and post-market support
• Strategic planning for Central Asian expansion

Our expertise in European and Eurasian regulatory affairs enables clients to successfully navigate complex regulatory environments and capitalize on opportunities in dynamically developing markets.

[1.] BioXconomy. “EAEU Pharmaceutical Harmonization Faces Critical Deadline as Member States Show Uneven Implementation Readiness.” November 6, 2025.

[2.] Proxima Research. “Pharmaceutical Market of Kazakhstan: Stability and Challenges.” September 11, 2025.

[3.] Insuvia. “Bringing the Dossiers into Compliance in the EAEU.” December 11, 2024.

[4.] RegAffairs.ru. “Registration and Examination of a Medicinal Product Under the Mutual Recognition Procedure in the Recognition State(s).” April 23, 2024.

[5.] LabMGMU. “Mutual Recognition Procedure for Marketing Authorization of Medicinal Products in the EAEU.” September 29, 2025.

[6.] Eurasian Economic Commission. “Registration Procedures for Medicines in EAEU Common Market Simplified.” June 19, 2025.

[7.] Kodeks. “EEC Council Simplifies Drug Registration Procedures in EAEU.” June 23, 2025.

[8.] RGTR. “How the EAEU Concept Will Create a Common Pharmaceutical Market for All Member States.” September 15, 2025.

[9.] Eurasian Economic Commission. “Rules for Drug Registration and Review Modified.” September 15, 2025.

[10.] RGTR. “Transition Period on EAEU Common Pharmaceutical Market Concludes.” November 20, 2025.

[11.] Proxima Research. “Kazakhstan Pharma Market Overview: Q1 2025.” August 26, 2025.

[12.] Times Central Asia. “Uzbekistan’s Pharmaceutical Market in 2025: Rapid Growth, Foreign Investment, and Localization.” November 10, 2025.

[13.] ITECA. “Pharmatech Kazakhstan 2025 Brochure.” 2025.

[14.] Statista. ““Other Pharmaceuticals - Central Asia | Market Forecast.” January 8, 2025.

[15.] IQVIA. “Key Tailwinds and Headwinds Impacting the Outlook for the Asian Pharmaceutical Market.” May 7, 2025.

[16.] Taube A.A. “Bringing a Drug Registration Dossier into Compliance with EAEU Requirements.” Bulletin of the Center for Expertise of Medical Products, 2023.

Learn more about our Drug Registration Services in CIS. → [CIS Registration]

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