Draft amendments to the Rules for marketing authorization and assessment of medicinal products for human use; (24 page(s), in Russian)
Draft resolution 1161, 18 May 2023; (6 page(s), in Portuguese)
Clinical Trials Regulations (145 pages, available in English and French) & Regulations Amending Certain Regulations Relating to Clinical Trials (8 pages, available in English and French)
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