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