Key developments in the regulation of medicines on the EAEU market

The Deputy Director of the Technical Regulation and Accreditation Department of the Eurasian Economic Commission (EEC) presented key developments in the regulation of medicines on the EAEU market at the XI All-Russian GMP Conference, including:

• the update of Annex 1 to the GMP Rules (sterile medicinal products);
• the introduction of Part 4 of the GMP Rules, which for the first time sets out specific requirements for the manufacture of advanced therapy medicinal products;
• the adoption of guidelines on temperature mapping and microbiological monitoring.

Particular attention was paid to EEC Council Decision No. 87 of 9 July 2026, which obliges the competent authorities of the EAEU Member States to apply the WHO Good Regulatory Practices (GRP). Unlike GMP and other practices aimed at manufacturers, GRP is aimed at regulators and concerns how the regulatory system is organised, how decisions are prepared and how their impact is assessed.

This review was prepared for the News section of the journal «Oʻzbekiston farmatsevtik xabarnomasi» (Pharmaceutical Bulletin of Uzbekistan).

Source: eec.eaeunion.org