ANVISA Worksharing: International Regulatory Cooperation to Accelerate Drug Approvals in Brazil

Brazil has become one of the most dynamic pharmaceutical markets in Latin America. In recent years, the Brazilian Health Regulatory Agency (ANVISA) has taken decisive steps to strengthen its regulatory framework and expand its role as a reference authority. One of the most important initiatives is worksharing— an international regulatory cooperation mechanism that accelerates drug approvals in Brazil through the joint evaluation of dossiers with other agencies.

Worksharing vs. Reliance on the ANVISA Regulatory Framework

Worksharing allows two or more regulatory authorities to review the same dossier simultaneously. Unlike regulatory reliance-where one authority builds on a decision already issued by another—worksharing requires active, parallel participation throughout the evaluation.

This approach has gained visibility through networks such as the International Pharmaceutical Regulators Programme (IPRP) and the Pan American Network for Drug Regulatory Harmonization (PANDRH), both encouraging regulatory convergence and international cooperation across markets.

ANVISA in action: accelerated approvals through cooperation

ANVISA has already shown a strong commitment to worksharing. In recent years, it has collaborated with the FDA, EMA, and Health Canada on pilot projects for the parallel evaluation of biologics and biosimilars. The agency also participates in Project Orbis, an international program designed to accelerate access to innovative oncology treatments.

More recently, ANVISA issued Instruction Normative 289/2024, regulating the use of assessments from Equivalent Foreign Regulatory Authorities (AREE) within the reliance framework. This move enables ANVISA to incorporate regulatory decisions from trusted agencies such as the FDA, EMA, or Health Canada—reducing duplication, expediting approvals, and reinforcing Brazil’s regulatory credibility.

Additionally, Technical Note 51/2025 updated post-registration processes for biological products, bringing greater transparency and predictability. These clearer guidelines help companies manage their portfolios more effectively in Brazil, especially when preparing CTD/eCTD submissions for complex products.

Together, these measures modernize the ANVISA regulatory framework and position Brazil as a reliable player in global regulatory cooperation— paving the way for the country to consolidate itself as a regulatory hub in Latin America.

What the pharmaceutical industry gains

For pharmaceutical and biotech companies, work-sharing in Brazil provides clear benefits:

• Accelerated drug approvals, avoiding repetitive reviews across countries.
• Greater transparency and predictability in regulatory pathways.
• Improved regional alignment, facilitating simultaneous submissions in Latin America.
• International recognition, thanks to parallel assessments with reference authorities.

In this landscape, having an expert who understands both ANVISA requirements and global regulatory expectations is critical. Freyr LATAM, with regional presence and global expertise, helps companies prepare robust dossiers and regulatory strategies aligned with work-sharing and reliance processes.

Challenges to overcome

The path is not without challenges. Worksharing requires dossiers harmonized in CTD or eCTD formats, full consistency in quality, safety, and efficacy data, and a clear communication strategy with multiple regulatory authorities.

ANVISA also maintains its own requirements for pharmacovigilance, labeling, and traceability, which must be integrated from the outset. At the same time, the agency faces operational constraints as demand for reviews continues to grow.

This makes preparation not only technical but strategic. Here, the expertise of specialized teams like Freyr is key—ensuring dossier alignment, embedding local requirements early, and enabling effective interaction with ANVISA’s regulatory framework.

Looking ahead: Brazil as a regulatory hub

ANVISA’s adoption of worksharing and reliance opens new opportunities for Brazil to strengthen its role as a regulatory hub in Latin America. These mechanisms enhance the credibility of its decisions and make the Brazilian market more attractive to global companies pursuing simultaneous launches.

Looking forward, ANVISA’s ambition to become a WHO Listed Authority reinforces its vision of being an international regulatory reference. For the industry, adapting to these models of international regulatory cooperation is no longer optional—it is a prerequisite for competing in a connected, global market.

Closing Remarks

Worksharing is more than a technical tool—it is a pathway to faster, more transparent, and globally connected drug approvals in Brazil. For pharmaceutical companies, anticipating this model is key to accelerating access to innovation and ensuring competitiveness in the region.

In this context, Freyr adds distinctive value by translating its global expertise into practical solutions tailored to ANVISA’s regulatory framework. International cooperation thus becomes not just an approval mechanism but a competitive strategy for successful launches in Brazil and beyond.