On May 29, the Brazilian Drug Market Regulation Chamber (Câmara de Regulação do Mercado de Medicamentos – CMED) published CM-CMED’s Rule #7, of May 28, 2026 (Rule #7/2026), which adjusts CM-CMED’s Rule #3, of December 29, 2025 (Rule #3/2025), which sets the criteria for pricing new drugs and new drug presentations. The changes had already been previewed in a CMED webinar held on May 25, 2026. As a result, Rule #3/2025 took effect on May 29, 2026, already incorporating the updates introduced.

Among the main changes brought by Rule #7/2026 are modifications to the definition of incremental innovation, the documentation requirements applicable to biosimilars, the rules concerning generic drugs, and the procedures for updating provisional prices.

With respect to incremental innovation, CMED removed from the previous text the provision that excluded from the definition the “marketing or manufacturing of new products entirely developed and produced by another company,” a scenario often seen in drug licensing deals.

For biosimilars, the documentation requirements have been simplified. The original version of Rule #3/2025 required the submission of a price information dossier along the same lines as those applicable to new drugs with a new Active Pharmaceutical Ingredient (API) in Brazil and no therapeutic gain over existing alternatives, including international pricing data. Under the new wording, biosimilars will now follow documentation requirements similar to those for generics and new presentations of products already on the market, reducing the potential regulatory burden on companies.

Rule #7/2026 also sought to clarify provisions relating to generic drugs. The industry had signaled that the previous wording could be interpreted to mean that a change in the reference drug’s price might automatically trigger a review of the corresponding generic’s price. According to CMED, the amendment is designed to dispel that concern by making it clear that the base price for review will always be the drug’s historical price, not the updated price of the reference product.

Finally, with regard to provisional prices, Rule #7/2026 amended Rule #3/2025 to provide that CMED’s Executive Secretariat will have 90 days to decide on the update of provisional prices.

Despite these adjustments, however, not all the issues the industry has been raising since Rule #3/2025 was published at the end of last year have been resolved. One of the main points of concern that Rule #7/2026 did not address is the possibility of using off-label treatments as a comparative benchmark for setting prices. In this context, although CMED changed the rule’s language to say that comparisons should consider treatments “preferentially on-label,” the text may still allow the use of therapies prescribed outside the indications approved by Anvisa (Brazil’s FDA).

Similarly, the potential retroactive application of the rule to drugs that are currently subject to provisional prices, as well as the possible need to submit information on a drug’s commercialization in reference countries in the context of risk-sharing agreements, were left unaddressed in Rule #7/2026.

The changes introduced by CM-CMED’s Rule #7/2026 show that the regulatory push to overhaul drug pricing rules in Brazil is ongoing, requiring close monitoring by pharmaceutical companies, especially with regard to the practical impacts of the new provisions and the future regulatory agendas announced by CMED.

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