Regulatory Trends for the Life Sciences Sector in 2026: 17 Key Topics for Companies Regulated by Anvisa, ANS, and MAPA
As 2026 begins, companies regulated by Brazilian Health Regulatory Agency (Anvisa), the National Supplementary Health Agency (ANS), and the Ministry of Agriculture and Livestock (MAPA) face a dynamic regulatory landscape. To support organizations in anticipating risks and preparing for strategic decision‑making, our Life Sciences & Healthcare team has identified 17 regulatory topics that will shape the sector throughout the year.
This report brings together analyses on nutrivigilance, medical device innovation, pricing of advanced therapies, health‑sector litigation, veterinary pharmacovigilance, and other highly relevant themes for regulated industries.
Explore the 17 topics we have identified for 2026:
- Food: Post‑market Monitoring and Enforcement Trends
- Cannabis: Revision of RDC 327/2019
- Regulatory Sandbox: Experimental Model and Next Steps
- Innovation, AI, and the Revision of RDC 657/2022 — Software as a Medical Device (SaMD)
- Note on Medical-device Innovation
- Revision of the Technovigilance Framework
- CMED Resolution 3/2025 and the new Internal Rules — What to Expect?
- New Resolution on Pricing of Advanced Therapies and Radiopharmaceuticals
- New Resolution on Extraordinary Medicine Price‑Adjustment Criteria
- Clinical Research: Expectations for 2026
- Eighteen months after Supreme Court Themes 6 and 1234: What to Expect for Injunctions in 2026?
- Healthcare‑Judicialization: Implementation Gaps in Precedents 6 and 1234
- Effects of ADI 7,265 — Legal Certainty and Sustainability in Supplemental Health
- ANS’s New Oversight Model for Supplemental Health
- Public Consultation No. 165 — Updating Portfolio-transfer Rules
- Veterinary Pharmacovigilance: Expected Sector Impacts
- Generic and Similar Veterinary Products: Therapeutic Equivalence and Reduced Animal Studies
Click here to download the full report and prepare for the key regulatory challenges ahead.
The Life Sciences & Healthcare team at Souto Correa Advogados is available for any questions on these topics via email: lifesciences@soutocorrea.com.br.