Brazil is a large country with over 200 million inhabitants, making it the largest population in Latin America. Divided into five regions, the country is the sixth largest pharmaceutical market in the world where regulatory compliance for clinical trials is upheld by an experienced and qualified workforce.
At first glance, these figures could be attractive to pharmaceutical and biotechnology companies. However, regulatory frameworks in Brazil are restrictive.
The regulatory process to approve clinical trials in the country requires approval by two entities, an ethical approval by CONEP (Comissão Nacional de Éticaem Pesquisa/National Ethics Commission) and a regulatory approval by ANVISA (Agência Nacional de Vigilância Sanitária/National Agency of Health Surveillance). Additionally, clinical trials require two ethical approvals, one by CONEP (as previously mentioned), which grants approvals at the national level and one at the local level by the institutional Ethics Committee (IEC). Both bodies have to approve the same package. For multicenter studies, a selected site is assigned as the coordinator site to get the first approval by its local IEC, before the site is approved by CONEP. Once the final approval is released by CONEP, each one of the remaining sites must also submit the study to obtain the approval from the local IEC. The timeframe for all these steps usually takes 90 days.
The sponsor is responsible to apply the package describing the study and related supplies, such as the medication, lab tubes and any equipment or medical devices to ANVISA’s evaluation. This application can be started after the first local ethics approval at the coordinator site. Bear in mind, the approval letter could take over 12 months to be released.
Combining the double ethics and regulatory approvals, the total lead time could easily exceed 12 or even 18 months. As a result, this long timeline usually forces trials in Brazil to start later than in their foreign counterparts.
In order to change this environment, ANVISA opened a public consultation in 2014 where over 600 suggestions were received. Multiple rounds of discussions took place throughout 2014 with local players, which brought about steady progress, from a regulatory standpoint.
Based on new rules and timelines released by ANVISA in March 2015, upon receipt of the Drug Clinical Development Dossier (DDCM), ANVISA has 90 days to evaluate it. If there is no response after receipt the clinical trial can be started after the relevant ethical approval by CONEP. It means that Tacit approval is applicable and valid for Phase III studies with small molecules.
For Clinical Developments of Biological Products (including vaccines) and Clinical Developments in Phase I or Phase II, the DDCM evaluation occurs within 180 days after receipt of DDCM by ANVISA and the clinical trial may be initiated only after approval by ANVISA. Tacit approvalis not applied for these clinical phases.