The Eurasian Economic Union (EAEU) continues to develop its single pharmaceutical market. According to the Eurasian Economic Commission, by early April 2026, more than 15,000 registration certificates had been issued in EAEU countries, and the total number of drug registration applications submitted exceeded 54,000. Furthermore, manufacturers have received over 3,600 GMP certificates confirming compliance with uniform good manufacturing practice requirements.
One of the key milestones was the end of the transition period: December 31, 2025, marked the end of the deadline for submitting applications to align registration dossiers with the Union's uniform rules. This means that the majority of drugs on the EAEU market now comply with common standards of quality, efficacy, and safety.
According to Alexander Subbotin, Minister for Technical Regulation of the Eurasian Economic Commission, some older drugs will not be converted to uniform requirements, as more modern and safer alternatives have emerged in recent years.
In 2026, the EAEU will focus on several major tasks. These include:
– completion of procedures for bringing registration dossiers of medicinal products into compliance with the requirements of the Union;
– updating the Union's GMP Rules. A new version of the Requirements for the Production of Sterile Medicines (Appendix No. 1) will be submitted to the Commission Council for consideration in June of this year. Part IV of the Rules, establishing the Requirements for the Production of High-Tech Medicines, is at an advanced stage of completion;
– the adoption of the fourth and final planned part of the first volume of the EAEU Pharmacopoeia. This is the culmination of extensive work on preparing the common pharmacopoeial monographs for the Union's regional Pharmacopoeia, which is the second regional pharmacopoeia in the world;
– creating conditions for improving the availability, safety, efficacy, and quality of medicines for use in pediatric patients, pregnant women, and lactating women. These patient categories are particularly vulnerable to the effects of medications, and therefore require more thorough study. Member states have included this area in the Action Plan ("roadmap") for the implementation of the Declaration on the Further Development of Economic Processes within the EAEU until 2030 and for the Period up to 2045 ("Eurasian Economic Path"), approved by EEC Council Resolution No. 39 of December 21, 2025.
The Eurasian Economic Commission (EAEC) notes that the geopolitical situation of recent years, despite its difficulties, has become an additional incentive for cooperation between states and the pharmaceutical industry within the EAEU.
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
One of the key milestones was the end of the transition period: December 31, 2025, marked the end of the deadline for submitting applications to align registration dossiers with the Union's uniform rules. This means that the majority of drugs on the EAEU market now comply with common standards of quality, efficacy, and safety.
According to Alexander Subbotin, Minister for Technical Regulation of the Eurasian Economic Commission, some older drugs will not be converted to uniform requirements, as more modern and safer alternatives have emerged in recent years.
In 2026, the EAEU will focus on several major tasks. These include:
– completion of procedures for bringing registration dossiers of medicinal products into compliance with the requirements of the Union;
– updating the Union's GMP Rules. A new version of the Requirements for the Production of Sterile Medicines (Appendix No. 1) will be submitted to the Commission Council for consideration in June of this year. Part IV of the Rules, establishing the Requirements for the Production of High-Tech Medicines, is at an advanced stage of completion;
– the adoption of the fourth and final planned part of the first volume of the EAEU Pharmacopoeia. This is the culmination of extensive work on preparing the common pharmacopoeial monographs for the Union's regional Pharmacopoeia, which is the second regional pharmacopoeia in the world;
– creating conditions for improving the availability, safety, efficacy, and quality of medicines for use in pediatric patients, pregnant women, and lactating women. These patient categories are particularly vulnerable to the effects of medications, and therefore require more thorough study. Member states have included this area in the Action Plan ("roadmap") for the implementation of the Declaration on the Further Development of Economic Processes within the EAEU until 2030 and for the Period up to 2045 ("Eurasian Economic Path"), approved by EEC Council Resolution No. 39 of December 21, 2025.
The Eurasian Economic Commission (EAEC) notes that the geopolitical situation of recent years, despite its difficulties, has become an additional incentive for cooperation between states and the pharmaceutical industry within the EAEU.
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
