ANVISA Selects Priority Foreign Authorities to Strengthen Regulatory Confidence

Medical device regulatory process accelerated by regulatory trust

Impact for Medical Device and Drug Manufacturers The National Health Surveillance Agency (ANVISA) approved, at a meeting of the Committee for Strategic Management, Risks and Institutional Innovation (CGE), the list of priority Foreign Regulatory Authorities. This decision aims to consolidate regulatory trust (“reliance”), accelerating registration and inspection processes of medicines and medical devices in Brazil. […]

Anvisa Publishes English Version of IN 289/2024: Regulatory Convergence and Efficiency

Anvisa Publishes English Version of IN 289/2024: Regulatory Convergence and Efficiency

How IN 289/2024 Facilitates the Registration and Post-Registration Process for Medicines and Biological Products in Brazil Anvisa has just released the English version of Normative Instruction (IN) 289/2024, reinforcing the agency’s commitment to international regulatory convergence. The new standard establishes procedures to streamline the registration and post-registration analysis of medicines, biological products, vaccines and Cadifas. […]