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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
Mali Profile Updated
Dec 5, 2024 - The Mali profile in ClinRegs has been reviewed and updated as follows:Additional details on training requirements for members of the Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB) (See Scope ...
DRC Profile Updated
Nov 27, 2024 - The DRC profile in ClinRegs has been reviewed and updated with the following information:Personal data protection requirements from a 2023 law (See Personal Data Protection)Supplementary Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) ...
India Profile Updated with DCGI Order Regarding Local Clinical Trial Waivers
Nov 26, 2024 - The India profile in ClinRegs has been updated to include an order issued by the Drugs Controller General of India (DCGI) specifying countries for which the DCGI may waive the requirement to conduct a local clinical trial if the new drug is already approved in one of the named countries and ...
Guinea Profile Updated
Nov 14, 2024 - The Guinea profile in ClinRegs has been reviewed and updated with the following information:Updated Ministry of Health and Public Hygiene (Ministère de la Santé et de l'Hygiène Publique (MSHP)) contact information (See Regulatory Authority)Updated National Ethics Committee for Health Research ...