Medicinal products

Draft amendments to the Guidelines for the preparation of a regulatory document on the quality of a medicinal product (69 page(s), in Russian)

The following are clarified:

·         the procedure for the preparation of a regulatory document on quality, taking into account the specifications for a medicine, including specifications for the active pharmaceutical substances (active substances, APIs), intermediates and finished pharmaceutical products, as well as pharmacopoeial monographs;

·        approaches to the identification and justification of the acceptance criteria (acceptable limits) and the identification of analytical methods used to evaluate these criteria.