Brazil’s regulatory framework for drugs is undergoing significant modernization, with updates spanning clinical trials, drug registration, pricing, and post-marketing surveillance.

• Clinical Trials & Drug Development
  Key Regulations:
  • Resolution RDC 945/2024: Governs clinical trials for drugs and biologics
  • Law No. 14,874/2024: Requires ethical review by research ethics committees (CEPs)
  • ICH Guidelines E6(R3): Adopted in 2025 for Good Clinical Practice

 

• Drug Registration & Marketing Authorization
  Updated Guidelines:
  • Resolution RDC 954/2025: Simplifies registration and renewal for drugs within the same economic group
  • Resolution RDC 912/2024: Sets MA validity periods (3–10 years depending on evidence)
  • Resolution RDC 753/2022: Covers synthetic, generic, and similar drugs
  • Resolution RDC 888/2024: Governs OTC drugs