Tapping the drug approval bureaucracy gap in Brazil

Is is well known that regulatory review for drug approval in Brazil is a long and bureaucratic process that takes an average of 2 years to be completed. ANVISA has been very candid about that issue. The regulatory agency is very open to listen to the demand of the industry and society to address the topic and discuss structural changes that can optimize the drug approval process and, in the meantime, still maintain the strict control that guarantees the population safety.

Various meetings are being held between the representatives from pharma in Brazil and government agencies, including the federal government’s Chief of Staff, Minister Gleisi Hoffmann, and ANVISA’s Chairman, Dirceu Barbano, in order to discuss potential measures that can overcome this gap in the industry.

One of the areas clearly identified as one of the causes of the long process of drug approval is the insufficient  manpower capacity of ANVISA, to keep up with the significant increase of the demand for drug approval from the industry.

By bringing together ANVISA, other foreign regulatory agencies and representatives from pharma in Brazil, the BioPharma Brasil 2013 Convention will allow these and other stakeholders to effectively discuss the necessary measures to overcome this considerable challenge in the Brazilian pharmaceutical market.

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