Brazil Modernizes Drug Pricing Framework with New CMED Regulation Effective April 2026
核心洞察
Brazil's Medicines Market Regulation Chamber (CMED (搜索)) enacted CM/CMED Rule No. 3/2025, replacing the 20-year-old pricing framework with a modernized system that takes effect on April 29, 2026.
The new regulation expands pricing categories from six to eight, broadens the concept of therapeutic gain beyond strict clinical superiority, and increases reference countries from 9 to 14 for international price benchmarking.
Companies must now demonstrate commercialization in at least four reference countries (up from three) for price approval, while Advanced Therapy Products (搜索) remain excluded pending separate regulatory guidance.
Brazil's Medicines Market Regulation Chamber (CMED (搜索)) has enacted a comprehensive overhaul of its drug pricing regulatory framework through CM/CMED Rule No. 3/2025, published in the Official Gazette on December 24, 2025. The new regulation, which takes effect on April 29, 2026, replaces the long-standing regime established under Rule No. 2/2004 and introduces a reorganized system for setting maximum entry prices for new medicines and presentations.
The reform responds to persistent criticism from the pharmaceutical industry that Brazil's pricing control model had become fragmented, increasingly discretionary, and insufficiently adapted to incremental innovation and technology-intensive products. The 120-day transition period is intended for companies to prepare pricing requests for products currently pending marketing authorization before Anvisa.
Expanded Pricing Categories and Therapeutic Gain
The new framework establishes eight pricing categories, expanding from the previous six, which serve as the primary determinant of applicable price ceilings and evidentiary requirements. Category 7 was created specifically for follow-on or non-incremental biologics, while Category 8 applies to cases of marketing authorization ownership transfers.
A particularly significant change involves the reformulation of the therapeutic gain concept. Under the former regime, therapeutic gain interpretation was often viewed as narrow and closely tied to strict clinical superiority criteria, which limited pricing recognition for products that introduced meaningful improvements in safety, tolerability, convenience, or treatment administration without necessarily demonstrating superior efficacy endpoints.
The new framework addresses this bottleneck by expressly allowing the Technical-Executive Committee to consider other scientifically supported therapeutic advantages beyond traditional parameters. The regulation clarifies the types of scientific evidence that may substantiate such advantages, moving beyond the previous focus solely on improved efficacy profiles, safety gains, and reduction of adverse effects.
For Category 1 medicines, which allow better pricing, the requirement that the active pharmaceutical ingredient be subject to a patent in Brazil has been removed. Now, it is only necessary for the medicine to present a therapeutic gain compared to available therapeutic alternatives in the country.
International Reference Pricing Changes
Rule No. 3/2025 expands the list of reference countries from 9 to 14, including Germany, Japan, the UK, Norway, Mexico, and South Africa, while removing New Zealand. The international reference basket plays a central role in CMED (搜索)'s drug pricing regulation, establishing a comparative framework for defining maximum entry prices.
At a meeting with industry representatives held by Anvisa on July 4, 2025, the agency emphasized that updating the basket aligns with good regulatory practices and aims to ensure greater alignment with current market conditions. Countries were selected based on factors including purchasing power for medicines, prevailing price levels, ease of access to official price information, and speed of new product market introduction.
The price cap for the wholesale segment (PF) will now be calculated based on prices in at least four countries, increased from the previous requirement of three. Where a product is not yet commercialized in at least four reference countries, CMED (搜索) will establish a provisional PF, and companies must thereafter submit annual documentation evidencing the product's launch and respective prices in reference jurisdictions.
Streamlined Timelines and Procedures
The new regulation establishes defined timelines for pricing analysis: up to 90 days for Categories 1, 2, and 3, as well as omitted cases, and up to 60 days for Categories 4, 5, 6, 7, and 8. The framework also defines a filing window for the Pricing Information Document (DIP), which must be submitted after filing the marketing authorization request and before publication of its granting.
If the DIP is not submitted within this window, CMED (搜索) will initiate a formal price-setting procedure and notify the responsible company to provide required documentation within 30 days. Should companies fail to comply, the Executive Secretariat will define the initial PF ex officio based solely on available information.
The regulation introduces a "Simplified DIP" modality for marketing authorization holders whose products already have established PF and who elect to adopt Anvisa's simplified procedures for registration, post-registration amendments, and renewals. In such cases, CMED (搜索) must complete its analysis within 60 days.
Advanced Therapy Products Gap Remains
Despite the comprehensive modernization, Rule No. 3/2025 expressly confirms that Advanced Therapy Products (搜索) (ATMPs (搜索)) remain outside the core categorization and pricing criteria established for new medicines and presentations. The regulation provides that pricing criteria applicable to ATMPs will be established through a specific act issued by CMED (搜索)'s Council of Ministers, and until such instruments are enacted, these products must be treated as omissive cases.
ATMPs (搜索) have historically lacked objective and tailored pricing parameters under Rule No. 2/2004, contributing to prolonged review cycles, multiple revisions, and higher propensity for litigation—ultimately delaying patient access. The persistence of this gap reflects the structural challenge of fitting ATMPs into a traditional price-cap model based on external reference pricing and conventional comparators.
Following targeted consultation conducted in 2025, CMED (搜索) has signaled an intention to advance regulatory treatment of ATMPs (搜索), with the regulated sector broadly expecting adoption of a specific pricing framework during 2026 to address the current gap and enhance predictability for advanced therapies.
Implementation and Transition
The new rule applies to ongoing proceedings, including DIP analyses pending before CMED (搜索)'s Executive Secretariat and provisional or omissive-case prices that have not yet been made definitive. Affected companies must supplement required documentation within 30 days of the rule's entry into force, failing which CMED may initiate a procedure to define the initial price, with procedural deadlines restarting upon submission of supplementary information.
The regulation also introduces mandatory review by CMED (搜索)'s Technical-Executive Committee, even in the absence of company appeals, for decisions issued by the Executive Secretariat in omissive cases and decisions where maximum PF for Categories 1 and 3 is defined based on company-proposed pricing rationale.