Draft resolution 1290, 28 November2024; (17 page(s), in Portuguese)

Draft amendments to the Rules for marketing authorization and assessment of medicinal products for human use; (24 page(s), in Russian)

Application Process and Requirements for Post-Approval Changes of Biological Products Adopting the World Health Organization Guidelines for Changes to Approved Vaccines and Biotherapeutic Products for Human Use; (91 page(s), in English)