CMED and the new regulatory framework: the market prepares itself for the new standard

On April 4, 2026, the Brazilian Drug Market Regulation Chamber (CMED) published CM/CMED Resolution No. 6/2026 to extend the entry into force of CMED Resolution No. 3/2025 by thirty days. Now, the new rule is expected to come into force on May 5, 2026.

In our experience, we have identified a market that is already anticipating itself for the new regulatory framework to reconfigure portfolio strategies, competitive positioning and product entry models, especially for companies with relevant biologics pipelines and for groups that structure M&A transactions in the pharmaceutical sector. The changes that will come should stimulate business reorganization and pricing movements and, above all, a more integrated performance between regulatory, market and legal areas. What we have observed is a growing demand for preventive analysis and regulatory strategies capable of anticipating risks and, above all, optimizing price dossiers.

With the new regulatory framework, CMED intends to improve concepts and improve regulation. CMED reorganizes and expands the categories of medicines for pricing purposes, as well as determining that the Price Information Document (DIP) be submitted while the health registration itself is being processed, among other novelties.

Of note is the creation of new categories of biological drugs (which are not classified as new products or as arising from incremental innovation) and drugs arising from the transfer of registration ownership – categories 7 and 8, respectively. Also noteworthy is the concept of incremental innovation – incorporated into category 3.

For instance, for a biological drug that is not innovative or incremental, the factory price (PF) must not exceed 80% (eighty percent) of the PF price of the originating biological drug.

With regard to drugs derived from transfer of ownership, in turn, in addition to other criteria provided for in the new regulatory framework, the way in which pricing is calculated will depend on the existence, or not, of the presentation of a drug with the same active pharmaceutical ingredient, concentration and pharmaceutical form that can be grouped in the portfolio of the successor company. This may impact business decisions regarding portfolio acquisition or mergers and acquisitions involving the transfer of health records of medicines.

With the entry into force of the rule, a period of thirty (30) days will begin for companies to submit a complement to the required documentation in cases subject to transition rules.

In addition to the new pricing regulation, there are other issues that still need a regulatory update by CMED, such as extraordinary price adjustment, among others.

Price regulation is one of the regulatory issues with the greatest impact on the pharmaceutical sector and its legal developments have gained relevance in recent years: either preventively (in the stage of preparation and submission of the DIP, or in the necessary complementation of documents provided for cases in transition); whether correctively, in appeals and other administrative procedures, or even in specialized judicial litigation, which will be impacted by the new regulation.