Updates | ClinRegs

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 ...

US Profile Updated with FDA Rule on Informed Consent Exceptions

Aug 27, 2024 - The United States profile in ClinRegs has been updated to include the Food and Drug Administration (FDA)'s final rule on informed consent exceptions for minimal risk clinical investigations, which took effect on January 22, 2024 (See Documentation Requirements). Sources ...

Brazil Profile Updated

Aug 23, 2024 - The Brazil profile in ClinRegs has been reviewed and updated with the following information:2024 legislation on principles, guidelines, and rules for conducting research with human beings and establishing the National System of Ethics in Research with Human Beings (See Oversight of Ethics Committees ...

Canada Profile Updated

Jul 26, 2024 - The Canada profile in ClinRegs has been reviewed and updated with the following information:Health Canada (HC) guidance on filing submissions electronically, including electronic Common Technical Document (eCTD) submission, non-eCTD electronic submission, and validation rules (See Submission ...