إجراء مقترح من تشيلي: الأدوية واللقاحات

Technical Guide G-BIOF 04 will form a new annex to Technical Standard No. 131, which defines the criteria for establishing therapeutic equivalence in pharmaceutical products in Chile. It will provide guidelines for demonstrating bioequivalence for dosage forms administered via the skin or mucous membranes, including topical, dermal, otic, ophthalmic, nasal, inhaled and transdermal routes, thereby addressing a regulatory need for those products where blood measurements are insufficient.In accordance with the principle of regulatory trust and the recommendations of the World Health Organization, this regulatory proposal seeks to harmonize the criteria established in practice by the Public Health Institute with the guidelines of the European Medicines Agency and the United States Food and Drug Administration, marking a milestone in terms of regulatory convergence.