On May 29, 2026, Resolution No. 3/2025 of the Chamber of Regulation of the Medicine Market (CMED) came into force, restructuring the methodology for setting the commercialization prices of pharmaceutical products in the country.
The standard replaces the former Resolution No. 2/2004, updating the categorization rules and factory price ceilings for new registrations and launches.
The main changes brought by Resolution No. 3/2025
Regulatory changes are divided into three major fronts:
Creation of new categories
The standard introduces two new rating bands:
- Category 7 (Biosimilars): It establishes a price cap, stipulating that the initial Factory Price (PF) may not exceed 80% of the reference originator biologic’s price.
- Category 8 (Transfer of ownership): it is intended for products undergoing registration changes, with specific pricing rules depending on the transmission scenario.
Ex officio price fixing
CMED assumes a stricter prerogative of active intervention. The agency may set prices (provisional or final) on its own initiative if the product obtains registration without an associated price after March 2004 or if the laboratory fails to submit the Price Information Document (DIP).
Adjustments to traditional categories
- Category 1: The ceiling price is now indexed to the lowest value practiced internationally among the comparison countries. The new feature is the end of the requirement for an active patent in Brazil to qualify for this modality.
- Category 3: limited to drugs with proven incremental innovation. If clinical superiority is not demonstrated, the launch price is capped at that of the existing comparator product.
- Categories 4 and 5: restructured to use market-weighted averages or those of presentations already commercialized by the same company and its economic group.
The impact for manufacturers and distributors
Resolution No. 3/2025 amends the starting point for the profitability of new products, requiring laboratories to revise their financial launch models and sanitary registration strategies.
For the biosimilars segment, the 80% cap set by the originator establishes a clear competitive limit. On the other hand, for high-tech medicines, the relaxation of patent requirements in Category 1 may benefit the pricing positioning of products with clinical advantages in the international market.
Drug Pricing in Brazil: What the New CMED Resolution Establishes
How did CMED limit the marketing prices of biosimilars?
The new rule classifies biosimilars under Category 7, stipulating that their initial factory price may not exceed 80% of the maximum approved price for the corresponding reference biologic.
Under what circumstances can CMED set prices through mandatory regulations?
The Chamber may establish prices ex officio if the manufacturer fails to submit the Price Information Document (DIP) or if there are older records without defined prices.
What changes in the pricing of innovative drugs without a national patent?
Under the new Category 1, the price cap is now set at the lowest international price among the list of reference countries, even if the drug’s patent is not registered in Brazil, thereby eliminating a long-standing barrier in the 2004 rule.
Life Sciences and Healthcare
Fialdini Einsfeld Advogados provides regulatory and legal advisory services to companies in the pharmaceutical sector, including matters related to drug pricing and categorization before CMED. Our team is available to assist clients in analyzing the impacts of Resolution No. 3/2025 and in developing regulatory strategies suited to the new regulatory framework.
