Brasília – Brazil’s Drug Market Regulation Chamber (CMED) published, on Wednesday, December 24, a new resolution revising the national framework for medicine pricing, updating the criteria used to define maximum prices at market entry and during post-approval adjustments. The measure represents one of the most significant revisions to Brazil’s drug pricing rules in recent years and reflects an effort to modernize regulatory tools while increasing transparency and methodological clarity.

The new framework expands the basket of reference countries used for international price benchmarking, refines the classification parameters for medicines, and updates the methodology applied to calculate factory prices and consumer price ceilings. According to CMED, the changes aim to align Brazilian pricing practices more closely with international standards while addressing distortions identified under the previous model.

Another relevant element is the introduction of clearer procedural stages and analytical criteria for price-setting and review requests. By detailing documentation requirements and timelines, the resolution seeks to reduce uncertainty for pharmaceutical companies during product launches and lifecycle price adjustments, a long-standing concern among market participants operating in Brazil’s tightly regulated pharmaceutical environment.

The resolution also formally replaces Resolution CMED No. 2/2004, which had governed drug pricing for more than two decades. The previous framework relied heavily on static international price comparisons and offered limited differentiation between types of medicines, with fewer procedural safeguards and less emphasis on technological or therapeutic innovation.

Under the new Resolution CMED No. 3/2025, pricing rules are substantially restructured, introducing a detailed taxonomy of medicine categories and clearly distinguishing between innovative products, incremental innovations, biological medicines and new pharmaceutical presentations. In addition, the regulation establishes the Documento Informativo de Preço (DIP) as a mandatory and standardized dossier, requiring companies to submit structured technical, clinical and economic evidence to justify proposed prices. The shift signals a move toward a more evidence-based and value-oriented pricing regime, which may raise preparation requirements for market entry but improve predictability and regulatory consistency over time.

Source: JOTA / Official Gazette

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