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Regulatory Focus™ > News Articles > Brazilian Legislators Looking for Enhanced Role in Multi-Country Clinical Trials

Brazilian Legislators Looking for Enhanced Role in Multi-Country Clinical Trials

Posted 19 March 2014 | By Louise Zornoza

At a hearing on enhancing pharmaceutical research in Brazil, the chair of the Senate Social Affairs Committee, Senator Waldemir Moka, called for the creation of a working group of government agencies and academic researchers who would prepare proposals on ways to bring multi-country clinical trials to Brazil. 

Another Senator, Ana Amelia, noted the possible need to revise the existing legal framework governing the conduct of clinical trials in the country, if necessary.

In response, the CEO of Anvisa, Dirceu Barbano, said it is important to improve the timeframes for the approval of clinical trials, but that that it is also important to ensure the rights and safety of clinical trial subjects.  Barbano added that the issue of enhancing Brazil as a site for clinical trials would be discussed this year, as part of the agency's Regulatory Agenda for 2013/2014.

 

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