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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
Peru Profile Updated with Additional Research Center Registration Requirements
Oct 31, 2024 - The Peru profile in ClinRegs has been updated to include the following:Requirement for the sponsor/contract research organization to ensure the research center is authorized in the specialty related to the proposed clinical trial (See Site/Investigator Selection)Requirement for research centers ...
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 ...