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Welcome
ClinRegs is an online database of country-specific clinical research regulatory information designed to assist in planning and implementing international clinical research. Countries are included based on NIAID's international clinical research priorities.
If a country you are looking for is not included in ClinRegs, consider the following resources:
- US. Department of Health and Human Services International Compilation of Human Research Standards
- European Clinical Research Infrastructure Network’s Regulatory & Ethical Database (RED)
ClinRegs Informational Resources:
Check out the following informational resources to learn more about ClinRegs:
- ClinRegs fact sheet
- May 2024 webinar recording: Utilizing NIAID’s ClinRegs Website to Support International Clinical Research Regulatory Compliance (see PDF for accessible version of presentation)
- NIAID ClinRegs—a Public Database of Country Clinical Research Regulatory and Ethics Requirements: Design and Utilization Analysis, Clinical Infectious Diseases, Volume 73, Issue 7, 1 October 2021, Pages 1296–1301, https://doi.org/10.1093/cid/ciab505
Updates
United States Profile Updated
Aug 14, 2026 - The United States profile in ClinRegs has been reviewed and updated with the following information:2025 Food & Drug Administration (FDA) guidance regarding sponsor and investigator responsibilities for safety reporting and additional adverse event reporting resources (See Safety Reporting)FDA ...
Brazil Profile Updated
Jul 31, 2026 - The Brazil profile in ClinRegs has been reviewed and updated with the following information:2025 and 2026 regulations, requirements, and additional resources related to the transition from the National Research Ethics Commission (Comissão Nacional de Ética em Pesquisa (CONEP)) system to the ...
India Profile Updated
Jul 28, 2026 - The India profile in ClinRegs has been updated with the following information:Reforms to India’s personal data protection framework and related requirements resulting from the implementation of the Digital Personal Data Protection Act, 2023 and Digital Personal Data Protection Rules, 2025 ...
Australia Profile Updated with the Latest Regulatory Fees
Jul 21, 2026 - The Australia profile in ClinRegs has been updated with the latest information on clinical trial fees, which came into force on July 1, 2026 (See Regulatory Fees).Sources Revised During This Update:(Guidance) Fees and Charges: Summary - From 01 July 2026 (G-FeesCharges) (Version 1.0) ...