Brazil's Backlog Is Nearly Clear, But Convergence Still A Work In Progress
Executive SummaryDrug application backlog has been distraction for agency and prevents focus on other projects, says ANVISA General Manager of Drugs Raphael Sanches Pereira.
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Latin America Notebook: Advancing Adaptive Trial Designs, Translating ICH Guidelines, Sharing Confidential Information
Brazil's drug regulator ANVISA will require more experience in dealing with adaptive trial designs before issuing guidance; translating older ICH guidelines remains a barrier to their implementation; and industry is asked to be more transparent in sharing their confidential information among drug regulators to facilitate convergence.
Anvisa is in the process of trying to reduce some of its red tape, but the excessive bureaucracy at COFEPRIS is likely to remain in place for the foreseeable future.