Understand how the new agreement between Anvisa and the FDA can speed up drug approval in Brazil and how QR Group can help your company comply.
The National Health Surveillance Agency (Anvisa) and the Food and Drug Administration (FDA), the regulatory body in the United States, have signed an important confidentiality agreement that will facilitate the exchange of information about drugs. The agreement, signed on October 30, aims to speed up and make more efficient the evaluation of drugs in Brazil, bringing direct benefits to public health.
What the agreement means for Brazil
Under this agreement, Anvisa will have access to strategic data on the safety, efficacy and quality of drugs that have already been evaluated by the FDA. This includes drugs in the pre-market and post-market phase, allowing the Brazilian agency to base its decisions on detailed analyses already carried out by the North American regulatory authority. This exchange of information strengthens trust between the agencies and allows Brazil to adopt international standards in drug analysis, accelerating the release of products on the market.
This collaboration also favors the implementation of Anvisa’s Normative Instruction (IN) No. 289/2024, which establishes criteria to optimize the analysis of drug, biological product and vaccine registrations, using the assessments of Equivalent Foreign Regulatory Authorities (AREE), such as the FDA. This means that the approval process for new drugs in Brazil can be more agile, ensuring that therapeutic innovations reach the market more quickly, without compromising safety or quality.
Direct impact on QR Group and the regulation of health products
For international companies seeking to regularize drugs in Brazil, this agreement between Anvisa and the FDA represents a significant opportunity. With the support of QR Group, companies can take advantage of this regulatory exchange to facilitate the introduction of their products into the Brazilian market. QR Group, a specialist in the regulation of health products with Anvisa, ensures that companies are always aligned with changes and optimizations in regulatory processes, offering agility and confidence in obtaining registrations.
With this international partnership, QR Group is even better prepared to help its customers navigate these new guidelines, using international data to ensure that their products meet all of Anvisa’s requirements more efficiently.
Conclusion
The data sharing agreement between Anvisa and the FDA reinforces the importance of international collaboration in the regulatory sector and accelerates drug analysis in Brazil. QR Group, with its vast experience in the market, is ready to help your company benefit from this new development, ensuring regulatory compliance and speeding up the drug registration process in the country.
If your company is seeking registration with Anvisa and wants to be up to date with international best practices, contact QR Group. Our team of experts is available to ensure that your product is on the market quickly and safely.
This article is from a reliable source: check out more at Correio Braziliense.
Photo: Agreement signed: FDA Commissioner Robert Callif and Anvisa CEO Antônio Barra Torres – (credit: Reproduction)
