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

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. Along with this launch, a Q&A document on regulatory confidence was published, offering companies clear guidance on how to align their processes with global best practices. QR Group, a specialist in health product regulation, is ready to help international manufacturers ensure compliance with these new requirements.

Impacts of IN 289/2024 on the Drug Registration Process

IN 289/2024 streamlines the registration process, allowing assessments made by Equivalent Foreign Regulatory Authorities (AREEs) to be considered in the analysis carried out by Anvisa. This facilitates access to high-quality medicines in Brazil, while maintaining rigorous safety and efficacy standards.

Regulatory Trust: A Key Concept for Global Convergence

Regulatory trust is a central element in the convergence of international regulatory practices. In practice, this means that Anvisa will be able to rely on the assessments of other National Regulatory Authorities (NRAs) to make faster and more informed decisions.

If your company operates in the healthcare sector and would like to learn more about how to comply with the new requirements of Anvisa’s IN 289/2024, contact QR Group. We are experts in ensuring regulatory compliance in an agile and efficient manner, ensuring that your product reaches the Brazilian market with complete safety.

IN 289/2024 not only streamlines the regulatory process, but also establishes an important milestone for international alignment. In this way, companies can count on greater agility when dealing with Anvisa’s requirements.

With the publication of the English version of IN 289/2024 and the new Q&A document on regulatory confidence, Anvisa demonstrates its commitment to efficiency and global regulatory convergence. QR Group, a specialist in healthcare regulation, offers complete support so that your company is always in compliance with Anvisa’s requirements.

Glossary:

AREEs: Equivalent Foreign Regulatory Authorities, which Anvisa considers in its assessments.
Cadifa: Letter of Adequacy of Active Pharmaceutical Ingredient Dossier, an essential document for drug approval.
NRA: National Regulatory Authority, government bodies that oversee the approval of medicines and biological products.