Brazil’s regulatory framework

Brazil’s regulatory framework News 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 DevelopmentKey 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 […]

Pharmacovigilance After the Windsor Framework

Pharmacovigilance After the Windsor Framework What MAHs Need to Know in 2025 The Windsor Framework, which came into effect on January 1, 2025, brings significant regulatory transformations to pharmacovigilance (PV) practices throughout the United Kingdom. In this new landscape, Great Britain (GB) adheres to the established UK PV legislation, while Northern Ireland (NI) remains committed […]