ANVISA proposes new rules to expedite the approval of clinical research in Brazil

The Brazilian National Health Surveillance Agency (ANVISA) recently presented a proposal with new rules to speed up the authorization of clinical trials of medical products in Brazil, writes Juliane Carvalho of Brazil Pharma News.

The proposal establishes a period of 90 calendar days in order for ANVISA to review all filings before the clinical study can resume. If the ANVISA does not respond within the 90 days period, the sponsor may start the clinical research provided it obtains approval from the responsible ethic review boards. However, this "automatic" 90 days release would not be extended to all clinical research cases and should cover about 70 % of what is today the agency considers as passive pending analysis.

The topic has been the subject of discussions between the Agency and the industry since 2012 and is the target of much criticism from the pharmaceutical industry which argues there are many delays in the authorization for clinical research. The industry argues that Brazil has stayed out of international biopharma research, with arms in different countries because of the bureaucracy.