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

    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 nec...
  • Brazil: Meeting to Discuss New Criteria for Therapeutic Indications

    The Board of Anvisa, the national regulatory authority of Brazil, is scheduled to review new regulations governing the format of "non-print" instructions for use of health products and the criteria for a therapeutic indication at its next public meeting. The Board will also receive a report by the Chief Executive Officer of Anvisa, Dirceu Barbano, on the international meeting of national regulators held in Geneva on 18 May that was organized by the agency on the topic of...
  • Brazil: Anvisa Restructuring to Meet Social, Economic Development Goals

    The Chief Executive of Brazilian regulatory authority Anvisa says the ongoing restructuring process at the agency is focused on the economic and social development of the country. The agency reforms are in recognition of a new Brazilian regulatory approach aiming to have a broader effect on society, said Dirceu Barbano, chief executive of Anvisa, in remarks before the Brazilian Congress on 8 May. "Having one eye on the country's economic development is one way to combat...