On September 18, ANVISA held, in Brasília, the Reliance Workshop. The event was held in a hybrid format, and Vita was represented in person by our consultant, Nayara Cordeiro, affairs specialist.

The event addressed the application of the reliance procedure and the progress achieved by the technical areas responsible for it: GGMED, GGBIO, AINTE, and GGFIS. The content was presented as a dialogue between the pharmaceutical industry and ANVISA, sharing the results achieved with the procedure and discussing ways to further promote its use.

Products filed through the reliance pathway must share the same characteristics as the product approved internationally by the Equivalent Foreign Regulatory Authority (AREE), demonstrating the concept of sameness. It is worth noting that, for GGBIO, the procedure has been applied quite successfully, with a high acceptance rate and reduced review times.

At GGMED, the reliance pathway differs from the other departments: the reliance amendment undergoes a screening step before the review begins, and if it is not accepted at that stage, the company has the opportunity to file again, with the documentation adjusted according to the instructions provided in an official letter. Among the areas presented, GGMED reported the lowest acceptance rates for applications filed through the reliance procedure. It is also the area with the smallest impact on queue reduction from this procedure, since domestic companies are not eligible to use it. Results from GGFIS could not be presented, due to a recent change to its workflow.

Regarding results, reliance leads to a significant reduction in review time, potentially reaching up to 50%, and also reduces both the number and complexity of deficiency letters. The main obstacle ANVISA has identified in using the procedure is companies filing incomplete documentation. Notably, ANVISA emphasized the importance of companies submitting the complete opinions issued by AREEs to ANVISA, not only the approval letters. The Agency mentioned that it has already requested these documents directly from other authorities, and that the EMA has a clear procedure for releasing them, while the FDA works under a submission quota, already reached by the Agency in 2026. It therefore reiterated that requesting these documents remains the companies’ responsibility.

In addition, ANVISA highlighted the need to assess any differences between the dossier to be filed and the one submitted to the AREE, which must be technically and scientifically justified. Brazil-specific requirements should not be an obstacle to using the reliance pathway.

Finally, the question that previously existed about sovereignty when using reliance has been settled, since the final decision is always made by ANVISA, which retains its technical responsibility for the final decision. The Agency’s goal is to become a reference and to be recognized for the procedure by all, or most, Latin American and Caribbean countries.