Latin America Notebook: Advancing Adaptive Trial Designs, Translating ICH Guidelines, Sharing Confidential Information
Executive Summary
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.
You may also be interested in...
Could New Governments In Brazil, Mexico Derail International Regulatory Convergence?
Bayer's Patrick Brady says nationalist sentiments raise concerns, but he remains hopeful that technology and progress will continue to drive globalization.
Latin America Inches Towards Greater Regulatory Harmonization
Regulatory harmonization is gathering pace in Latin America, which is good news for pharmaceutical companies.
Brazil's Backlog Is Nearly Clear, But Convergence Still A Work In Progress
Drug application backlog has been distraction for agency and prevents focus on other projects, says ANVISA General Manager of Drugs Raphael Sanches Pereira.