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Regulatory Requirements

The Global Health Nework's partner area, The Global Health Regulatory Requirements Database, is a unique resource designed to help researchers and regulatory affairs professionals access the information they need to develop effective strategies for gaining approval to conduct clinical trials and market products. The database includes high-level regulatory information on a variety of countries in Africa, Asia, and Latin America, as well as links to key guidance documents and other resources where users can find more detailed information. Information users can access includes: contact information for national regulatory authority regulators, information on the country’s IRB structure, an overview of clinical trial and product registration data requirements, costs, and timelines, and post-registration pharmacovigilance requirements.

The Global Health Regulatory Requirements Database offers users easy navigation from country to country, and separates technology-specific information into three categories—drugs, vaccines, and diagnostics. Information will be reviewed and updated regularly to ensure its accuracy, as well as to expand the country and data offerings included.

The database was developed by the Global Health Technologies Coalition, housed at PATH, with funding from the Bill and Melinda Gates Foundation. For more information, visit the website: http://regulatory.ghtcoalition.org/.