Brazil OKs fast-track for device and pharma trial applications
This article was originally published in Clinica
Executive Summary
Brazilian proposals to fast-track the licensing-assessment of a large proportion of the clinical trial applications it receives have been approved. Pending the formal publication of the enacted resolution by regulatory agency Anvisa and the precise detail of the policy, the government has issued a statement confirming that applications involving trials already approved in the EU, US, Japan, Australia or Canada will be fast-tracked. As described in a public consultation in May (www.clinica.co.uk, 10 May 2012), the measure is expected to halve the approval time: an estimated 80% of all applications would be processed within 90 days, said Anvisa. At the time, Brazil reported a backlog of over 100 applications. The new regulation will not affect the procedure for assessing the ethical aspects of trial applications, which will remain the responsibility of the national research ethics committee, Conep.