Brasília – The National Health Surveillance Agency (Anvisa) plans to expand its regulatory reliance model, adding new Equivalent Foreign Regulatory Authorities (AREE) to accelerate the evaluation of medicines, active pharmaceutical ingredients, and medical devices.

Among the upcoming changes, Anvisa intends to include Japan’s Pharmaceutical and Medical Devices Agency (PMDA) and strengthen cooperation with the European Medicines Agency (EMA) and Health Canada, which will also begin supporting active ingredient assessments. The agency reported that, between 2024 and 2025, 36% of reliance requests remain under review, while only 5% have been finalized.

According to Anvisa, expanding reliance mechanisms will enhance international regulatory convergence, reduce duplication of technical work, and speed up access to innovative health technologies in Brazil, particularly for products already approved by trusted agencies.

Source: Futuro da Saúde

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