CMED Postpones New Drug Regulation

The Brazilian Drug Market Regulation Chamber (Câmara de Regulação do Mercado de Medicamentos – CMED) has extended by 30 days the effective date of CMED’s Rule #3, dated December 29, 2025 (“Rule #3/2025”), which was originally scheduled to enter into force yesterday, April 29, 2026. Rule #3/2025 consolidates the regulatory framework for drug price regulation in Brazil and redefines the criteria and procedures applicable to the pricing of new products and new product presentations, replacing former CMED Rule #2/2004.

The extension was formalized by CMED Rule #6, dated April 28, 2026, published yesterday in the Federal Official Gazette. The new rule amends Article 52 of Rule #3/2025 to provide that it will enter into force 150 days after its publication date, replacing the previously established 120-day period. Under this revised timeline, Rule #3/2025 will enter into force on May 29, 2026, which now becomes the reference date for the implementation of the new regulatory rules.

CMED’s decision to postpone the entry into force of Rule #3/2025 follows significant pressure from the pharmaceutical industry. Since its publication, stakeholders have repeatedly raised concerns not only regarding the lack of clarity of certain concepts and terms used in the new regulation, but also with respect to the substantive changes introduced by the new pricing rules. In this context, the extension was granted to allow such concerns to be further reviewed and discussed by CMED together with industry representatives. Accordingly, the expectation is that during this additional 30-day period, these discussions may result in changes or adjustments to the text of the regulation as originally published.

Our team remains available to assist in the interpretation of this measure and its potential regulatory impacts.