CM-CMED Rule #3/2025 (“New Rule”), published in the Official Gazette on December 24, 2025, and republished on December 30, 2025, to correct formalities, introduces significant changes to the regulation of drug pricing in Brazil. The rule follows the draft submitted for public consultation between May and July of this year and reflects adjustments based on the contributions received.

The Drug Market Regulation Chamber (CMED) has updated the regulatory framework for setting drug prices in Brazil, introducing new rules and consolidating interpretations that had previously been applied in a fragmented manner.

The final wording of the New Resolution preserves the structure of the draft submitted for public consultation, while adjusting the proposed text in certain specific points. The main changes are:

a) The New Rule expands and reorganizes existing categories of medicines for pricing purposes, increasing from six to eight categories. Category 7 was created for follow-on or non-incremental biologics (previously treated mostly as cases that do not fall within any established category), and Category 8 applies to cases of transfer of ownership of marketing authorizations. The New Rule also reorganized the treatment given to medicines with incremental innovation, consolidating all such scenarios under Category 3, which was broadened to include new combinations, routes of administration, concentrations, or dosage forms that demonstrate clinical advantage.

b) Regarding Category 1 (which allows better pricing), the requirement that the API be subject to a patent in Brazil for a medicine to qualify has been removed. Now, it is only necessary for the medicine to present a therapeutic gain compared to available therapeutic alternatives in the country.

c) The concept of “therapeutic gain” was also modified, allowing the Technical-Executive Committee to consider other scientifically proven “therapeutic advantages” beyond those listed in the rule (e.g., better efficacy profile, safety, and reduction of adverse effects).

d) The method for demonstrating therapeutic gain now has clearer rules, with an express reference to the types of “scientific evidence” that will be accepted.

e) As for timelines, CMED established up to 90 days for the analysis of Categories 1, 2, and 3, as well as omitted cases, and up to 60 days for Categories 4, 5, 6, 7, and 8.

f) The list of reference countries for external price benchmarking was expanded from 9 to 14, with the inclusion of Germany, Japan, the United Kingdom, Norway, Mexico, and South Africa, and the exclusion of New Zealand. Acceptance of the price cap for wholesale segment (known as “PF” in the Portuguese acronym) also became stricter, now requiring commercialization of the medicine in at least four countries from the list (previously only three were required).

g) The Price Information Document (DIP) now has a defined submission period, after the application for marketing authorization and before its publication by Anvisa (Brazil’s FDA). If the DIP is not submitted, CMED may set a preliminary or definite PF for new products or new presentations (Article 9). In such cases, the Executive Secretariat will notify the company to provide the documentation within 30 days; if no response is given, the price will be set ex officio based on available information.

h) Furthermore, when a medicine’s MA depends on additional data and evidence after its granting, CMED may set a provisional price until the necessary information for definitive pricing becomes available (Article 13). The decision must indicate the essential data or await compliance with the commitment term signed with Anvisa. During this period, the company must submit technical reports with evidence of efficacy and safety according to the agreed schedule, under penalty of legal sanctions. CMED has up to 90 days after full compliance or delivery of the information to define the final price; if it does not act within this period, the provisional price remains valid until a final decision.

i) The New Rule also created the “Simplified DIP”, intended for companies that already have defined prices and choose faster registration procedures.

j) The Rule introduces new technical criteria, such as the concept of groupable dosage forms, a price cap for non-new biologicals (limited to 80% of the originator’s price, with the possibility of a single price), and mandatory review by the Technical-Executive Committee of decisions in omitted cases or based on rationale proposed by the company.

k) Advanced therapy products will continue to be treated as omitted cases until a specific regulation is issued by CMED's Council of Ministers (Article 45).

The New Rule enters into force 120 days after its publication, on April 29, 2026. It is important that this 120-day period be used by companies to prepare price requests for products subject to pending registration applications at Anvisa, as they will need to be filed before the publication of the granting of registrations.

Finally, regarding the impact of the New Resolution on ongoing proceedings, it applies to DIP analysis processes pending in the first administrative instance of the Executive Secretariat, omitted cases under review in the first administrative instance of the Technical-Executive Committee, and products with provisional prices that have not yet become definitive (Article 46). Companies must supplement the required documentation within 30 days of the Rule’s entry into force; if they fail to do so, they will be notified to submit the documents within a new 30-day period. Failure to comply will result in the initiation of a procedure to define the initial price of the medicine. The deadlines for DIP analysis will restart upon delivery of the supplementary documentation.

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