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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
UK Profile Updated with HRA’s Revised Reporting Requirements
Oct 25, 2024 - The United Kingdom profile in ClinRegs has been updated to include the Health Research Authority (HRA)’s revised progress and safety reporting processes, which took effect UK-wide on August 1, 2024. (See Safety Reporting, Progress Reporting, and Risk & Quality Management).Sources Added ...
Canada Profile Updated with Additional Details on Therapeutic Products Oversight and ICH Guidelines Implementation
Oct 1, 2024 - The Canada profile in ClinRegs has been updated with the following information:Information related to the Minister of Health’s regulatory authority regarding therapeutic products that may present a risk of injury to health (See Regulatory Authority)Webpage providing details on Health Canada’s ...
Zimbabwe Profile Updated
Sep 18, 2024 - The Zimbabwe profile in ClinRegs has been reviewed and updated with the following information:Additional details on the Medicines Control Authority of Zimbabwe (MCAZ)’s reliance model from its 2024 policy (See Scope of Assessment)Additional details related to MCAZ application requirements ...
Malawi Profile Updated
Aug 29, 2024 - The Malawi profile in ClinRegs has been reviewed and updated with the following information:Data protection requirements related to the processing of personal data and the rights of data subjects (See Personal Data Protection)Additional details and requirements related to the import of investigational ...