Russian Embassy in Sri Lanka

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Chinara Mambetalieva presented key innovations in regulating medicines circulation in the EAEU market Chinara Mambetalieva, Deputy Director of the Eurasian Economic Commission's Technical Regulation and Accreditation Department, spoke at the plenary session of the 11th All-Russian GMP Conference “A New Decade of GMP: Innovation, Safety, Reliability” held in Stavropol. 📋 The EEC representative informed about the key indicators of the Eurasian registration and inspection system, highlighting the main innovations for 2026. These include an update to Annex 1 of the GMP Regulations, the introduction of Part 4 of the GMP Regulations, which for the first time enshrined specific requirements to the manufacture of advanced therapy medicinal products, and the adoption of guidelines on temperature mapping and microbiological monitoring. Chinara Mambetalieva drew particular attention of the conference attendees to Decision No. 87 of the EEC Council dated July 9, 2026, which requires the authorized bodies of the Eurasian Economic Union countries to apply the WHO Good Regulatory Practices (GRP). Unlike GMP and other good practices directed at manufacturers, the GRP regulations are targeted at regulators and concern how the system is structured, how decisions are made, and how their impact is assessed. The conference hosted an off-site meeting of the Working Group on Pharmaceutical Inspections to Ensure Compliance with Good Pharmaceutical Practices in the Circulation of Medicines within the EAEU. The meeting was attended by representatives of the Member States' inspectorates. The 11th All-Russian GMP Conference is the leading sector-specific forum to discuss the application of Good Manufacturing Practices. This year’s conference program covers the updates in GMP, contract manufacturing, the manufacture of biopharmaceutical products, licensing and inspections, as well as the functioning of the EAEU common market. 🌍 The event is attended by representatives of regulatory authorities, expert organizations, and pharmaceutical manufacturers from the Union States, as well as international experts from South Africa, Indonesia, and the African Medicines Agency. #EAEU

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