On April 14, 2026, the EEC Board adopted Resolution No. 49 on the draft Decision of the Council of the Eurasian Economic Commission “On Amendments to the Rules of Good Manufacturing Practice of the Eurasian Economic Union.” The Board proposed approving the draft Decision and submitting it for consideration by the EEC Council. The Decision concerns amendments to the EAEU GMP Rules, approved by Decision No. 77 of the Council of the Eurasian Economic Commission dated November 3, 2016 (hereinafter referred to as the Rules). These amendments pertain to Annex No. 1 “Requirements for the Manufacture of Sterile Medicinal Products.” The Decision shall enter into force upon expiry of 180 calendar days from the date of its official publication, with the exception of paragraphs 4.11, 4.12, 8.87, 8.88, 8.108, 8.124 and 8.136 of Annex No. 1 to the Rules (taking into account the changes introduced by the Decision) – they will enter into force upon expiry of 1095 calendar days from the date of official publication of the Decision.
Structure of the updated Annex No. 1:
- Scope
- Principle
- Pharmaceutical Quality System
- Premises
- Equipment
- Utilities
- Personnel
- Production and specific technologies
- Environmental and Process monitoring
- Quality Control
- Glossary
The Annex has become more comprehensive, the number of pages has increased to 145. The subsection “Barrier Technologies” in the section “Premises” has almost doubled. The topics of background environment, gloves and decontamination methods have been dealt with separately for Isolators and Restricted Access Barriers Systems (RABS). The subsections “Form-Fill-Seal (FFS)” and “Blow-Fill-Seal (BFS)” in the section “Production and Specific Technologies” have almost tripled in scope and go into much more detail. In addition, there are further deletions, summaries and new insertions in many sections, as well as rewordings. One of the most important new requirements in the updated Annex No.1 is a Contamination Control Strategy (CCS).
In the EU, a similar updated Annex No. 1 (Manufacture of Sterile Medicinal Products) has been included in the European Union GMP Guidelines (EudraLex – Volume 4, EU GMP) and is fully applicable from 25 August 2024. At the same time, from July 16, 2026, the new Commission Implementing Regulation (EU) 2025/2091 will come into force for veterinary medicinal products, which contains Annex I “Sterile Products and Aseptic Manufacturing”, which has its own characteristics.
