CMED updates rules for pricing medicines

Resolution CM/CMED No. 3/2025 represents a significant advancement in the economic regulation of the pharmaceutical sector by establishing new rules for the definition of launch prices and the categorization of medicines. The normative text further details essential concepts, such as therapeutic alternative, innovative activity, therapeutic gain, and incremental innovation, which become decisive factors in determining the maximum price allowed for medicines in the Brazilian market.

Below are the most relevant aspects of the new resolution:

Classification of medicines

The resolution establishes the criteria for classifying medicines into specific categories, which serve as the basis for price regulation.

New products, defined as those containing an active pharmaceutical ingredient (“API”) not previously authorized in Brazil, are divided into two categories:

• Category 1 – products with proven therapeutic gain over available alternatives;
• Category 2 – products that do not demonstrate additional clinical benefit.

For new presentations, six additional categories apply:

• Category 3 – products featuring incremental innovation, such as new combinations, single-agent formulations, routes of administration, strengths, dosage forms, packaging, or other relevant technological improvements;
• Categories 4 and 5 – new presentations without significant innovation, distinguished by the level of grouping with existing pharmaceutical forms;
• Category 6 – generics;
• Category 7 – biological products that do not qualify as new products or incremental innovations.

The regulation also provides for exceptional situations, such as the possibility of not considering the grouping of pharmaceutical forms when there is scientific evidence justifying differentiation. In addition, the resolution establishes that medicines classified by the National Health Surveillance Agency (“ANVISA”) as innovative will be placed in Category 3, provided they meet the definition of incremental innovation. Cases not covered by the established categories will be treated as omissions, subject to technical analysis by the Medicine Market Regulation Chamber (“CMED”).

Pricing criteria for advanced therapy products and radiopharmaceuticals will be defined in separate normative acts. Until then, such products will be treated as omitted cases for implementation purposes of CM/CMED Resolution No. 3/2025.

Documents required for defining the Factory Price

Under the new rules, companies applying for sanitary registration must submit to CMED a request for price definition accompanied by the DIP – a compilation of administrative and technical documents – aimed at establishing the product’s Factory Price (“PF”) at launch in Brazil. The DIP must be submitted after the filing of the health registration application and before approval is published in the Federal Official Gazette. Additionally, companies must monitor the registration process before ANVISA.

The DIP must include a primary document, signed by the company’s legal representative, presenting the justification for the price request and the information required for the product’s category. The studies and opinions related to the medicine must be submitted as annexes to the DIP, and their amendment is permitted for the inclusion of complementary information at any time, up to the publication of the registration.

However, as of the entry into force of the new regulation and upon notification of the interested companies, CMED may initiate an ex officio procedure to define the PF of registered products that do not have an established price or whose respective DIP has not been submitted prior to the publication of their registration.

Criteria for PF definition

The resolution establishes parameters for the definition of the PF and provides that, as a general rule, the price proposed by the company for the medicine cannot exceed the lowest price charged for the same product in the reference countries, plus applicable taxes.

Reference countries include: South Africa, Germany, Australia, Canada, Spain, the United States, France, Greece, Italy, Japan, Mexico, Norway, Portugal, and the United Kingdom, in addition to the product’s country of origin, where applicable.

If the product is not yet marketed in at least four of the reference countries, CMED will establish a provisional price for the product. In turn, the registering company must annually submit to CMED’s Executive Secretariat documents proving the product’s launch in those countries – with its respective price – until this criterion is met, under penalty of sanctions and fines.

Conversely, if the product is not yet marketed in other countries, pricing will be based on products containing the same API and groupable pharmaceutical form in the reference countries.

When therapeutic alternatives are considered, treatment cost will be calculated using technical parameters such as indication, line of therapy, route of administration, and dosage regimen.

The regulation also allows for flat pricing across presentations with different strengths, provided the therapeutic effect is equivalent or where international prices are uniform.

In addition to the general provision, category-specific rules include:

• Category 1 (new API with therapeutic gain) – ceiling price set by the lowest international price; a company-proposed rationale may be used where no international reference exists or if the product was developed in Brazil;
• Category 2 (new API without therapeutic gain) – price capped at the comparator’s treatment cost and limited by the lowest price applied in reference countries;
• Category 3 (incremental innovation) – special pricing allowed if demonstrating additional benefit, such as improved safety or greater system efficiency;
• Categories 4 and 5 (new presentations) – price based on weighted or arithmetic averages;
• Category 6 (generics) – cannot exceed 65% of the reference medicine;
• Category 7 (non-innovative biologicals) – 20% discount relative to the originator, with the possibility of a uniform price;
• Category 8 (transfer of holder) – limits linked to the previous holder’s pricing history.

Review and decision-making process

CM/CMED Resolution No. 3/2025 establishes a detailed workflow for price-definition applications, ensuring enhanced transparency and predictability. Decisions on request  compliance will be supported by a technical opinion. In this case, companies may request a hearing to present and substantiate the scientific evidence included in the DIP. For claims of additional clinical benefit, CMED may consider documents already submitted to ANVISA during the sanitary registration process.

Decision deadlines will vary according to the category of the medicine:

• Up to 60 days – new presentations (Categories 4 to 8);
• Up to 90 days – new products (Categories 1 to 3) or omitted cases, counting from registration publication.

Deadlines may be extended once, for an equal period, and will be suspended if CMED requests clarifications or supplementary documentation. If CMED fails to issue a decision within the deadline, the corresponding medicine may be commercialized at the proposed price until the final decision is issued.

Requests from the Ministry of Health will be prioritized, resulting in a reduction of deadlines by half. In addition, the regulation governs the right of appeal: decisions of the Executive Secretariat may be challenged before the Technical-Executive Committee within 30 days, with the possibility of reconsideration at first instance. Specific decisions, such as those involving omitted cases or special pricing criteria, are subject to mandatory review, even without an appeal by the company.

Transitional rules

In addition to its application to new cases arising from its entry into force, the new rules established in Resolution CM/CMED No. 3/2025 also apply in the following situations:

• To DIP analysis proceedings pending judgment at first instance before CMED’s Executive Secretariat;
• To products classified as omitted cases, which are pending before the Technical-Executive Committee for judgment at first instance; and
• To products that have provisional prices established under CMED Resolution CMED No. 2 of March 05, 2004, which have not yet become definitive.

Applicant companies requesting a medicine price under the situations described above must submit the supplementary documentation required by the resolution within 30 days from its effective date. If the supplementary documentation is not submitted within the established deadline, CMED’s Executive Secretariat will notify the applicant company to comply with the requirement, under penalty of filing an ex officio proceeding to determine the medicine’s initial PF.

Demarest’s Life Sciences & Healthcare team remains available to provide assistance and clarify any additional questions.