IN FOCUS
Regulatory
New rules for pharmaceutical price regulation
CM/CMED Resolution No. 3/2025 was published on December 30, 2025, but may be considered, in practice, a 2026 regulation, as its market impact materialized in January and its entry into force is scheduled for April 29, 2026.
The resolution reorganizes pricing criteria, strengthens the procedure for the Price Information Document (Documento Informativo de Preço – DIP), and updates the regulatory framework to reflect current realities, with direct implications for biologics, advanced therapies, incremental innovations, and similar products.
Operational guidelines for clinical research
On January 13, 2026, the Ministry of Health issued Technical Note No. 1/2026, setting forth operational guidance for the transition from the former National Research Ethics Commission (CONEP) model to the new National Research Ethics Authority (INAEP).
The guidance seeks to prevent operational discontinuities, including exceptional extensions of accreditation for Research Ethics Committees (RECs) and interim workflows for higher-risk protocols and studies sponsored by the Ministry itself.
At the same time, the note highlights areas of concern, such as potential bottlenecks at accredited RECs and operational uncertainties relating to biobanks.
New regulatory framework for medicinal cannabis
On January 28, 2026, Brazil’s Health Regulatory Agency (ANVISA) placed medicinal cannabis at the center of the regulatory agenda, amid strong institutional pressure for clearer rules—including a deadline imposed by the Superior Court of Justice (STJ)—and expanding business opportunities.
The debate reflected a pragmatic approach, focusing on controlled-environment cultivation, traceability, and criteria distinguishing scientific evidence and safety from ad hoc practices. This approach tends to mitigate litigation and enhance regulatory predictability.
The new regulatory framework, published in early February (RDCs Nos. 1,011 to 1,015/2026), makes clear that all links in the supply chain will now face heightened requirements for control, quality, and accountability, while also unlocking broader market opportunities.
Incorporation of a new cancer treatment into private health insurance coverage
On January 26, 2026, the National Supplementary Health Agency (ANS) decided to include momelotinib in the List of Health Procedures and Events (Rol), for a specific subset of myelofibrosis patients.
The drug will be classified under “Oral Antineoplastic Therapy for Cancer Treatment” and must be covered by private health insurers as of March 2, 2026.
Regulatory Agendas – ANS (2026–2028) and ANVISA (2026–2027)
ANS extended the public consultation period for its 2026–2028 Regulatory Agenda until February 27, 2026, and reaffirmed the implementation of its new inspection model, effective May 1, 2026, which promises a more selective, data-driven supervisory approach.
ANVISA has approved its 2026–2027 Regulatory Agenda, comprising 161 priority topics, primarily focused on medicines, food, medical devices, and cross-cutting issues. The agenda entered into force on January 1, 2026, and will be subject to public monitoring of timelines and regulatory progress.
New Special Control Regime for controlled veterinary substances
On January 2, 2026, the Ministry of Agriculture and Livestock (MAPA) issued Ordinance No. 837/2025, establishing a new Special Control Regime for controlled substances used in veterinary medicine and products containing them.
The regulation imposes stricter rules governing procurement, registration, prescription, dispensing, labeling, and inventory control. Notably, veterinary products containing tetrahydrocannabinol (THC) below 0.2% are exempt from the special control regime.
The ordinance repeals prior regulations from 2017 and 2018, signaling a modernization of the regulatory framework and alignment with a broader post-market surveillance agenda, including strengthened veterinary pharmacovigilance to address risks to animals, humans, and the environment.
Tax
Tax Reform in the healthcare sector
The year 2026 marks the beginning of the transition period for Brazil’s tax reform, with companies already adapting their systems for the implementation of the IBS and CBS, particularly regarding new ancillary obligations currently under testing.
Within this context, Supplementary Law No. 227/2026 redefined the criteria for applying a zero rate of IBS and CBS to medicines, linking the benefit to specific therapeutic categories and requiring the publication, every 120 days, of an updated list of eligible products. The law also included medicines covered by the Farmácia Popular program (or equivalent) among eligible items.
While serums and vaccines were already covered under Supplementary Law No. 214, Law No. 227 expanded the benefit to encompass any serum and any vaccine, regardless of prior listing—significantly broadening the scope of the incentive.
Importantly, the list under Law No. 214 does not fully overlap with the new categories introduced by Law No. 227, requiring careful analysis by companies to ensure compliance and anticipate tax impacts.
Reduction of tax benefits (Supplementary Law No. 224)
Another key development in early 2026 was the enactment of Supplementary Law No. 224, which mandated a 10% reduction in tax benefits provided for both in the law itself and in the Tax Expenditure Statement (Demonstrativo de Gastos Tributários – DGT) supporting the 2026 Annual Budget Law.
Companies should assess whether the incentives they effectively use fall within the scope of the reduction, such as:
- the presumed credit under the positive list set forth in Law No. 224;
- the increased zero rate of PIS/COFINS for products under Chapters 29 and 30, as provided in the DGT.
Certain benefits are expressly excluded from the reduction, including those related to the Lei do Bem, as recognized by the Brazilian Federal Revenue Service, as well as incentives that, by their nature, are not subject to reduction—such as zero rates under monophase taxation regimes.
A detailed mapping of utilized tax benefits is essential, as the reduction may directly impact operational tax costs. Market discussions have also raised the possibility of challenging benefits provided solely in the DGT, due to the lack of its formal incorporation into the Budget Law or potential violations of the annual tax non-retroactivity principle.
PRESS
_Rubens Granja commented on and authored pieces regarding ANVISA’s decision on medicinal cannabis, highlighting it as an important milestone of institutional maturity. He also analyzed, for Futuro da Saúde, the impacts of ANVISA’s new regulatory agenda and the priority areas defined for the healthcare sector in 2026.
Check out the articles from Agência Estado and Conjur, as well as the piece in Futuro da Saúde, where Rubens Granja analyzes the impacts of Anvisa’s new regulatory agenda and the priorities defined for the healthcare sector in 2026. (Available in portuguese)
RADAR ALERT
_ANVISA approves a new regulatory framework for medicinal cannabis in Brazil. (Available in portuguese)
This material is for informational purposes only. Our Life Sciences & Healthcare team is available to provide specific legal advice.
