Abstract

REGULATORY LANDSCAPE FOR THE REGISTRATION OF GENERIC DRUGS IN EAEU COUNTRIES

Bukkisetti Gopi*, M. V. Nagabhushanam and M. Beena Devi

ABSTRACT

The regulatory landscape for the registration of generic drugs in the Eurasian Economic Union (EAEU) is designed to harmonize procedures and standards across its member states—Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia. The framework emphasizes alignment with international guidelines, including the use of the Common Technical Document (CTD) format and the demonstration of bioequivalence to reference drugs. A centralized and mutual recognition registration process ensures a single approval is valid across the region, promoting efficiency and reducing duplication. Despite these advancements, challenges such as administrative differences and language barriers among member states remain, requiring ongoing harmonization efforts to optimize the system and enhance access to affordable medicines.

Keywords: Eurasian Economic Union (EAEU), Generic products, Common Technical Document (CTD).