Latin America Inches Towards Greater Regulatory Harmonization
Regulatory harmonization is gathering pace in Latin America, which is good news for pharmaceutical companies.
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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.
Bayer's Patrick Brady says nationalist sentiments raise concerns, but he remains hopeful that technology and progress will continue to drive globalization.
African health ministers have agreed on a treaty to set up a new pan-African agency to coordinate regional drug regulatory harmonization initiatives and pool limited regulatory expertise.