Fast Track for Clinical Trials
Posted 07 May 2012 | By
Brazil is trying to encourage companies to conduct clinical trials locally and is proposing Public Consultation No. 30, a simplified clinical trial application review procedure cutting in half the time now taken for approving a clinical trial in Brazil.
In order to qualify for the expedited procedure, the trial would have to have already been approved in one or more of the following countries: Europe, US, Japan, Australia or Canada.
Two additional regulatory changes being implemented to facilitate clinical trials include easing the rules on the import of medicines and products that will be tested in country, and allowing a company to transfer research work to another company without the need for a re-evaluation of the research - a procedure known as global studies transfer.
Approval of clinical research will be simplified - Anvisa