Updates
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 ...
Mexico Profile Updated
Nov 8, 2024 - The Mexico profile in ClinRegs has been reviewed and updated with the following information:Details for electronically submitting research protocol authorization requests via DIGIPRiS, the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS)’s Digital Research and Clinical ...
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 ...
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 ...
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