Anvisa published normative instruction (IN 289/2024) and guidelines on Regulatory Reliance

Anvisa makes available in its webpage three important updates that reinforce the Agency's commitment to transparency and regulatory efficiency. The first document is the set of Guidelines on Regulatory Reliance (document in Portuguese: Perguntas e Respostas sobre a aplicação da confiança regulatória). The second is the Normative Instruction n. 289/2024 (available in English version). To complement the updates, Anvisa added new documents to the registration checklist, to help companies prove comparison conditions of drugs, as approved by Equivalent Foreign Regulatory Authority (AREE).

Regulatory reliance is a concept that has been widely discussed worldwide. It refers to a regulatory convergence aiming to align national practices to global practices. This procedure occurs when a National Regulatory Authority (NRA) acknowledges the evaluation conducted by a Foreign Regulatory Authority or even by a reliable institution, to support its decisions. This kind of practice enables access to quality drugs, benefits companies and consumers, while optimizing the use of resources.

Anvisa included the Regulatory Reliance as a priority theme in its Regulatory Agendas (2021-2023, and 2024-2025). In 2022 the Agency conducted a Public Consultation (CP n. 1108), to discuss the temporary regulatory reliance for drugs and biological products regulation. After the consultation Anvisa published the Normative Instruction n. 289/2024, to optimize the analysis of marketing authorization or post-approval change applications of drug products, biological products, vaccines in Brazil. This norm allows that the evaluation carried out by other regulatory authorities be considered by Anvisa’s analysis. This enables maintaining standards of quality, safety, and efficacy in the country.    

The new guideline document clarifies key questions about the subject, offering practical guidance to companies on how to provide information and documents, which makes the regulatory process easier.

Publishing these materials reinforces Anvisa's commitment to promote regulatory efficiency and to increase access to essential drugs, always ensuring the safety and quality of products available to the Brazilian population.