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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
Brazil Profile Updated
Jun 27, 2025 - The Brazil profile in ClinRegs has been reviewed and updated with the following information:National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA))’s 2024 clinical trial regulation has been incorporated into the profile (See the Regulatory Authority, Clinical ...
Zimbabwe Profile Updated with New MCAZ Fee Schedule
Jun 5, 2025 - The Zimbabwe profile in ClinRegs has been updated to include the Medicines Control Authority of Zimbabwe (MCAZ)'s new fee schedule, which was issued on April 30, 2025, and details the fees effective from January 1, 2025. (See Regulatory Fees)Sources Added During this ...
South Africa Profile Updated with the Latest Regulatory Fees
May 28, 2025 - The South Africa profile in ClinRegs has been updated as of March 31, 2025, with the latest information on clinical trial application fees and payment instructions, effective February 13, 2025. (See Regulatory Fees)Sources Added During this Update:(Communication) Newly Gazetted Regulation Regarding ...
United States Profile Updated
May 20, 2025 - The United States profile in ClinRegs has been reviewed and updated with the following information:Information on the Food & Drug Administration (FDA’s) Electronic Submissions Gateway Next Generation (ESG NextGen) platform, which went live on April 14, 2025 (See Submission Process)Department ...