CMED amends resolution on medicines pricing, but regulatory concerns remain

The Brazilian Medicine Market Regulation Chamber (CMED) published CM-CMED Resolution No. 7/2026, which changes the new regulatory framework for medicine pricing (CM-CMED Resolution No. 3/2025). Both resolutions entered into force on May 29, 2026, ending the effective date delay of the latter.

Key changes introduced by CMED Resolution No. 07/2026 include:

• Definition of “additional benefit” (Art. 2, II-A)

Defined as the benefit offered by the medicine compared to the therapeutic alternatives registered in the country, which may include additional clinical benefit, increased patient safety, or efficiency gains for the healthcare system, including through the reduction of costs associated with the treatment. The changes integrate economic efficiency as a pricing element and define the documents that must be submitted in the Price Information Document (DIP) (Art. 7, XVII).

• Revision of the definition of “groupable pharmaceutical form”

To be deemed groupable, therapeutic indications now must also coincide (Art. 2, VII).

• Definition change of “incremental innovation”

No longer includes the marketing or manufacturing of new products fully developed and produced by another company (Art. 2, IX).

• Restructuring of the DIP’s documentation requirements (Art. 7):

This includes adjusting the required documents list based on the product category and the company’s strategy for demonstrating the additional benefit or the production and development process in Brazil.

• Pricing based on international prices

In such cases, the proposed Ex-Factory Price (EWP) may not exceed the lowest EWP charged in the reference countries, plus applicable taxes (Art. 10).

• Immediate marketing

Applies to products classified in categories 5 (new formulation, same portfolio), 6 (generics), or 8 (resulting from a transfer of ownership) upon publication of the marketing authorization and compliance with specific articles of the regulation:

o Category 5: the price must comply with the ceiling set based on the average of equivalent presentations already sold by the company itself or by the economic group (Art. 23).

o Category 6: the price may not exceed 65% of the reference medicine’s price, considering the value set when the medicine entered the domestic market, adjusted for inflation. Furthermore, the reference price for the generic medicine may not exceed the current reference price of the reference medicine (Art. 24).

o Category 8: the price must comply with:

• the history of the transferred formulation, if the successor does not have in its portfolio a medicine formulation with the same active pharmaceutical ingredient (API), concentration, and groupable dosage form; or
• the average of the successor company’s presentations, if the successor has, in its portfolio, a medicine presentation with the same API, concentration, and groupable pharmaceutical form (Art. 27).

CMED Resolution No. 07/2026 sought to clarify concepts, reorganize documentation requirements, and improve procedural aspects of the pricing process. However, the changes do not fully address all concerns raised by the regulated sector.

Despite noted improvements, significant aspects of the new regulatory framework are still viewed critically by the sector, for example:

• Off-label comparators: the regulation establishes that the therapeutic indication should be “preferably” based on the package insert or on robust evidence (Art. 12, paragraph 1), leaving room for the use of comparators whose therapeutic indication has not been duly approved in the marketing authorization granted by the Brazilian Health Regulatory Agency (ANVISA).
• Sharing of sensitive information: the disclosure of information regarding risk-sharing agreements executed in other markets, including contractual terms and agreed-upon prices (Art. 7, X), may conflict with confidentiality obligations assumed toward third parties, in addition to creating uncertainty regarding the impacts of this mechanism.

As a result, the new resolution has entered into force with an immediate need for improvements, especially regarding legal certainty, the transparency of objective criteria, and regulatory predictability, in line with Brazil’s challenging economic landscape.

CMED Resolution No. 03/2025 marked an attempt to technically improve and modernize the regulatory framework for medicine pricing. Improving such regulation, however, largely requires a continuous process of social participation and collaboration with regulated entities.

Demarest’s Life Sciences & Healthcare team is available to provide any further clarification that may be necessary.