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05.10.2022

EAEU clarified requirements for regulatory document on quality of pharmaceuticals

The Eurasian Economic Commission’s Board has approved amended version of the Guidance for preparing a regulatory document on the quality of pharmaceuticals.

The updated Guidance details instructions for drafting a regulatory document on quality used to control the quality of pharmaceuticals from their release until shelf-life expiration. This document is specific to the Eurasian region and is made up on the basis of specifications for pharmaceuticals, including active pharmaceutical ingredients (active ingredients), intermediates and finished medicinal products.

The algorithm of selecting pharmacopoeial procedures and approaches to selecting and justifying permissible standards (tolerance) of pharmaceutical quality attributes and selecting analytical procedures used to evaluate these indicators was presented.

"The adopted decision considers the accumulated experience of the EAEU countries’ laboratories evaluating the quality of medicines during their registration, as well as proposals of pharmaceutical manufacturers with due regard to the practice of filing marketing authorization applications", noted Viktor Nazarenko, EEC Minister in charge of Technical Regulation.