Joint initiative aims to expedite clinical research in Brazil

Representatives from universities, scientific research institutions and the pharmaceutical industry created the Alliance for Clinical Research in Brazil aiming to expand clinical research in the country and reduce regulatory approval time, writes Juliane Carvalho of Brazil Pharma News.

The alliance was launched by members arguing that the bureaucracy created by regulators hinders the advancement of clinical studies as it may take a year or up to 15 months for clinical study approval. The Brazilian legislation is considered by most to be very complex, and the delay in the approval of projects by the Clinical Research Ethics Committee (CEP) and the National Commission of Ethics in Clinical Research (CONEP), and the National Health Surveillance Agency (ANVISA) discourages the pharmaceutical industry.

However, CEP/CONEP representatives believe there is much exaggeration in the way pharmaceutical companies have ‘given up’ on Brazil, and they insists that the government is working hard to reduce delays. Data published by the new alliance group shows there are 3,784 ongoing clinical studies throughout the country, a total which represents only 2.32% of all clinical studies in the world.