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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
Canada Profile Updated with the Latest Drug Submissions and Applications Guidance
Dec 19, 2025 - The Canada profile in ClinRegs has been updated with the latest version of the Guidance on Management of Drug Submissions and Applications, which took effect on October 1, 2025. (See Regulatory Authority, Submission Process, and Timeline of Review)Sources Revised During this Update:(Guidance) ...
DRC Profile Updated
Dec 16, 2025 - The DRC profile in ClinRegs has been reviewed and updated with the following information:Clinical trial application requirements and form for the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) (See Scope of Assessment, Scope of ...
South Africa Profile Updated with the Latest SAHPRA Clinical Trials Committee Meeting & Submission Dates
Dec 16, 2025 - The South Africa profile in ClinRegs has been reviewed and updated with the South African Health Products Regulatory Authority (SAHPRA) clinical trials committee meeting and submission dates for 2026 (See Scope of Assessment, Submission Process, and Timeline ...
Mexico Profile Updated
Dec 9, 2025 - The Mexico profile in ClinRegs has been reviewed and updated with the following information, which is current as of October 31, 2025:2025 data protection legislation and related information regarding public information transparency and access, strengthening private party rights, and regulating ...