The Drug Market Regulation Chamber (CMED) has published Resolution CM/CMED No. 3/2025, which establishes a new regulatory framework for the pricing of medicines in Brazil, replacing rules that had been in force for more than two decades. The resolution introduces relevant changes to product classification criteria, pricing methodology and administrative procedures applicable to companies operating in the pharmaceutical sector.

Resolution No. 3/2025 promotes a structural reorganization of the pricing regime by introducing new categories of medicines and setting differentiated criteria for the definition of the Factory Price, considering the degree of innovation, the existence of comparator products and the competitive environment.

In this context, the express recognition of incremental innovation as a relevant element for pricing purposes is particularly noteworthy, as it may positively impact strategies related to the development of new presentations, combinations, pharmaceutical forms or routes of administration. The regulation also provides specific treatment for biological products, biosimilars and generics, as well as for situations involving transfer of marketing authorization ownership, with direct effects on the applicable price.

The new resolution significantly reinforces the role of the Price Information Document (DIP) within the regulatory process. The DIP becomes an essential condition for price definition and must be submitted after the filing of the marketing authorization application with  Brazilian Health Regulatory Agency (Anvisa) and prior to the publication of the approval decision. Failure to submit the DIP, or submission in non-compliance with the applicable requirements, may result in ex officio price setting by the CMED, substantially increasing the regulatory and economic risks associated with the process.

In addition to procedural reinforcement, the technical content required in the DIP has been expanded, with greater emphasis on regulatory justifications, scientific evidence and, where applicable, pharmacoeconomic elements. Although the resolution provides for the possibility of a simplified DIP in specific cases, its applicability will depend on a case-by-case assessment.

Resolution CM/CMED No. 3/2025 also updates the international price referencing criteria used to define the Factory Price:

• The proposed Ex-Factory Price may not exceed the lowest price practiced in the reference countries.
• The list of reference countries has been expanded to cover 14 jurisdictions.
• The adoption of a definitive price will require evidence of commercialization in at least four of these reference countries, failing which a provisional price will be established.

These changes are expected to have a direct impact on global launch strategies and market sequencing, particularly for innovative medicines and recently approved products.

With respect to administrative proceedings, the resolution establishes maximum timeframes for the review of pricing applications, which vary according to the category of medicine. While these deadlines contribute to greater regulatory predictability, they may be suspended in the event of technical requirements or additional requests for information, reinforcing the importance of robust and technically consistent submissions from the outset.

Overall, the new regulatory framework represents a relevant advancement in terms of systematization and transparency. At the same time, it imposes a higher level of technical sophistication on regulated companies. A proper understanding of the new categories, strategic preparation of the DIP and alignment between regulatory, legal and market access teams will be critical to mitigate risks and preserve economic value.

The resolution will enter into force following a 120-day vacatio legis period counted from its republication, with effects expected as of April 2026.