Realities of EAEU Pharmaceutical Registration

Welcome to DDReg Knowledge Capsule! In this episode, we unpack the complexities of pharmaceutical registration across the Eurasian Economic Union (EAEU)—covering Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan.While the EAEU Unified Procedure establishes a harmonised regional pathway for multi-state marketing authorisations, obtaining approval and maintaining post-market compliance still requires navigating critical member-state requirements.Key topics covered in this episode: Unified Procedure vs. National Pathways: How the reference-state and concerned-state evaluation system works, and when pursuing a national pathway (such as Russia’s Federal Law No. 61-FZ) may be strategically advantageous. EAEU CTD Dossier & Language Strategy: Navigating the 5-module CTD structure, managing local clinical data expectations, and addressing Russian, Armenian, and Kyrgyz translation requirements early. Post-Registration Fragmentations: Why a unified marketing authorization does not mean unified post-market compliance—exploring separate national pricing/reimbursement frameworks, distinct packaging/labelling guidelines, and non-centralised pharmacovigilance reporting systems (such as Roszdravnadzor in Russia). Post-2025 Compliance Realities: What marketing authorization holders need to know following the December 31, 2025 transition deadline for aligning legacy national registrations with EAEU rules For more check out blog - EAEU Pharmaceutical Registration: What’s Not Unified Procedure