Written by Thea Collier-Lawlor, Senior Analyst: [email protected]
Pricing in Brazil is about to undergo the most significant reform in the last 20 years, with the implementation of new rules on 29 April 2026*. Resolution No. 3/2025, published by the Brazilian Drug Market Regulation Chamber (CMED) in December 2025, replaces the long‑standing Resolution No. 2/2004 and is set to modernise price‑setting criteria to reflect changes in pharmaceutical innovation, while increasing procedural transparency and predictability in CMED’s decision‑making.
The implementation has been delayed to 30th May 2026 due to industry feedback and ongoing discussions around key aspects of the framework, including data requirements and procedural clarity, resulting in the transition period being extended]
The resolution results directly from Public Consultation No. 1/2025 (May–July 2025) (see previous LI post) and incorporates stakeholder feedback, judicial guidance from the Supreme Federal Court, and internal regulatory experience accumulated since 2004.
Key updates from the new resolution encompass drug classification, price setting criteria, and expanded DIP (Price Information Document) requirements. The updated regulation affects not only new submissions but also pending or ongoing cases that are in the system as of April 2026.
New Drug Classifications
The updated product framework increases the total number of categories from the 6 simplistic categories that were present in Resolution 2/2004 to 8 modular and value-based categories, as mapped in Table 1:
Category 1: products with a new active pharmaceutical ingredient (API) that demonstrate therapeutic gain over currently available treatment options
- A key policy shift is the removal of the requirement for products in Category 1 to be patented in Brazil
- The definition of therapeutic gain has also been broadened. The Technical-Executive Committee may now consider additional scientifically proven therapeutic advantages beyond those explicitly listed in the rule, such as improved safety or fewer adverse effects
Category 2: products with a new API that do not demonstrate therapeutic gain over currently available treatment options
Category 3: products with incremental innovation
- This new category formally recognises incremental innovation, including new combinations, dosage, routes of administration, or other improvements that provide a demonstratable clinical or systemic benefit
Category 4: non‑groupable new presentations of existing products without incremental innovation
- The product cannot be grouped with existing ones due to a different pharmaceutical form or different clinical handling / administration
- E.g., the existing product is a 50mg oral tablet, and the new product is a 50mg injectable solution, with the same outcomes, but it cannot be grouped with tablets
Category 5: groupable pharmaceutical forms of existing products
- E.g., existing product is a blister pack of 30 tablets, and the new presentation is a blister pack of 60 tablets
- Categories 4 and 5 have been developed to prevent artificial price inflation via line extensions, but allowing differentiation when clinically justified
Category 6: generics
Category 7: biological products that are not classified as a new product or as originating from incremental innovation (biosimilars)
Category 8: products whose marketing authorisation (MA) has been transferred from one company to another after the product has already been registered and priced in Brazil e.g., if the company sells the product to another company
Categories 7 and 8 are new additions to address gaps that led to uncertainty for biosimilars and M&A related transactions in Resolution 2/2004
Table 1: Comparison of the previous product criteria from Resolution 2/2004 against the updated Resolution 3/2025
Price Setting and IRP
Resolution 3/2025 also strengthens the use of international reference pricing (IRP) by expanding the basket of reference countries from 9 to 14, adding Germany, Japan, the UK, Norway, Mexico, and South Africa, while removing New Zealand*. Additionally, the country of origin, meaning where the product was first registered and launched commercially, may be considered where relevant. If a product is commercialized in fewer than four of these reference countries, CMED will assign a provisional factory price. Companies must subsequently demonstrate launches and prices in additional countries, or risk sanctions or downward price adjustments.
Based on the drug classification, certain referencing and pricing rules will be applied when determining factory price (PF). In addition, there are specific circumstances in which CMED may determine the PF based on the rationale proposed by the company. See below for further detail:
Category 1: Pricing is generally capped by the lowest price in the IRP basket; however, where no international reference price exists or where product development and production are carried out in Brazil, CMED may establish the PF based on the company’s proposed rationale
Category 2: The PF is limited by the cost of treatment compared to therapeutic alternatives available in Brazil
Category 3: Assuming the product is able to demonstrate additional benefit over the original product, PF may equal or exceed the original product’s price; otherwise, it may not exceed the originator’s price. Category 3 products demonstrating additional benefit, in the event of absent or lower international prices, or local development and manufacturing, are also entitled to CMED determining PF based on company rationale
Category 4: The PF is determined using internal benchmarks, with reference to the prices of existing presentations of the product that are already marketed
Category 5: Group-based internal pricing is used to set the PF, where the new presentation is included in a pricing group of similar presentations. The PF may not exceed the highest equivalent price in that group
Category 6: Pricing is capped at 65% of the reference product PF in Brazil
Category 7: The PF may not exceed 80% of the reference biologic’s price, with the possibility of a single unified price for originator and follow‑on product, potentially leading to price erosion of the originator
Category 8: A change in the holder of the marketing authorisation does not justify repricing; the factory price remains linked to the product’s existing approved price and pricing history, ensuring price continuity following transfers of ownership
CMED introduced new defined review periods, in which they analyse the DIP and set the factory price. Price analyses for Categories 1, 2, and 3, as well as omitted cases, may take up to 90 days to complete. Reviews for Categories 4, 5, 6, 7, and 8 are limited to 60 days. The time starts from the publication of the marketing authorisation, provided the DIP has been submitted, and there are clock stops where the review period is suspended if CMED issues a request for clarification or additional documentation, with the clock resuming once the company responds. If justified, CMED may extend the original deadline once, for the same duration. If CMED fail to issue a decision within the review period, the company may market the product at the price proposed in the DIP, until CMED formally communicates its decision. There is no mechanism requiring rebates or refunds if the final factory price is set below the temporarily applied price.
This new mechanism was introduced to address historic delays and improve regulatory certainty. Under Resolution 2/2004, there were no binding review timelines, and pricing decisions often took many months, particularly for products claiming therapeutic gain. This structural change improves predictability for launch planning and rebalances power between CMED and companies by implementing procedural consequences for delays.
Price Information Document (DIP)
In the new resolution, the DIP evolves into a mandatory structured dossier that combines administrative, regulatory, economic, and scientific data to support pricing requests. The DIP must be submitted any time between the filing and publication of the MA, with the MA publication serving as a functional deadline.
In addition to traditional IRP data, the DIP may now include:
- Evidence of therapeutic gain or incremental innovation
- Pharmacoeconomic studies
- High level information on risk-sharing or managed-entry agreements in reference countries, such as the type of agreement and general structure
- Documentation demonstrating healthcare resource utilisation (HCRU) gains or safety improvements, even if outside of the direct efficacy advantages
Failure to submit a compliant, on time DIP allows CMED to set factory prices ex officio, either provisionally or definitively.
Conclusion and P4A Insights
The approval of Resolution 3/2025 marks a necessary evolution in Brazil’s drug pricing framework and introduces a structural shift for manufacturers looking to launch their products in Brazil. This new framework, including establishing defined review timelines, clarifying category-specific pricing criteria, and enforcing a robust DIP, will reduce procedural uncertainty and regulatory drift. Overall, this creates a clearer pathway from regulatory to agreed pricing, and an opportunity to accelerate patient access to medicines in Brazil, provided companies prepare robust evidence packages and align on their strategies from the outset. Although advanced therapy medicinal products (ATMPs) are not covered by this new regulation, and separate guidance will be published later, the introduction of clearer procedures and timelines remains highly relevant for these products, as procedural uncertainty has historically been a key factor delaying ATMP launches in the Brazilian market.
It is clear 2026 will be a year in which pricing and economic regulation within CMED will continue to attract significant attention, especially given CMED’s stated intention to further refine the framework through dedicated rules for ATMPs, radiopharmaceuticals, and pricing issues linked to judicialization.
We at Partners4Access will continue to monitor CMED’s ongoing regulatory developments. Proactively interpreting how new pricing criteria and category rules are applied in practice will be crucial when supporting our clients in shaping evidence strategies and navigating submissions to mitigate risk and preserve value in Brazil’s evolving environment.
*Full list of reference countries: Australia, Canada, France, Germany, Greece, Italy, Japan, Mexico, Norway, Portugal, South Africa, Spain, United Kingdom, United States.
References:
1. https://www.demarest.com.br/cmed-atualiza-regras-para-a-precificacao-de-medicamentos/
3. https://www.mattosfilho.com.br/unico/cmed-marco-precificacao-medicamentos/
