Development of unified approaches to aligning registration dossiers with EAEU requirements

In the context of establishing a common pharmaceutical space within the Eurasian Economic Union (EAEU), the unification of registration dossiers is becoming a key prerequisite for the effective functioning of the mutual recognition mechanism. This article examines the regulatory and institutional barriers that hinder alignment with a unified format, despite the formalized structure of the Common Technical Document (CTD). A comparative legal and structural-content analysis of requirements for Modules 1, 3, and 5 across EAEU member states is conducted, identifying typical discrepancies and their implications for applicants. Based on the research results, an adaptive transformation algorithm is proposed, along with unified templates and checklists suitable for use in a digital regulatory environment. The hypothesis that comprehensive unification reduces administrative burden, shortens review times, and enhances the transparency of regulatory decisions is confirmed. The article includes recommendations for digital integration of dossier adaptation mechanisms and explores the prospects for implementing eCTD technologies and artificial intelligence in regulatory practice.