Brasília – The Drug Market Regulation Chamber (CMED) has submitted for legal review the draft of a new resolution that will redefine how medicine prices are established in Brazil. The proposal replaces the current Resolution No. 2/2004 and seeks to modernize the regulatory framework to reflect market dynamics, international benchmarking, and transparency principles in price formation.

According to the Ministry of Health, the new text updates the mechanisms for price setting, review and monitoring, introducing clearer methodologies for classifying products, calculating ceiling prices and applying discounts or rebates. It also revises the rules for pricing innovative medicines, generics and similar drugs, with the aim of improving predictability for manufacturers and expanding access for patients.

The document’s submission to legal analysis represents the final step before publication. Once reviewed and approved, the new regulation will be signed by CMED’s Executive Secretariat and published in the Official Gazette. The measure is expected to bring greater regulatory stability to the pharmaceutical sector and ensure more balanced price control consistent with Brazil’s economic and public-health objectives.

Source: JOTA