Updates | ClinRegs

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 ...

Bangladesh Profile Updated

Jul 16, 2024 - The Bangladesh profile in ClinRegs has been reviewed and updated with the following information:Updated Directorate General of Drug Administration (DGDA) guidelines on good clinical practice (GCP), including revisions related to the DGDA review of clinical trial protocols, oversight of institutional ...

Uganda Profile Updated with Revised NDA Service Delivery Timelines

Jul 10, 2024 - The Uganda profile in ClinRegs has been updated to include the National Drug Authority (NDA)'s revised service delivery timelines (See Timeline of Review).Sources Revised During this Update:(Webpage) National Drug Authority – Service Delivery Timelines (UGA-24) (Current ...

Australia Profile Updated with Revised TGA Fee Schedule

Jul 3, 2024 - The Australia profile in ClinRegs has been updated to include the Therapeutic Goods Administration (TGA)'s revised fee schedule, which took effect on July 1, 2024 (See Regulatory Fees).Sources Revised During this Update:(Guidance) Fees and Charges: Summary - From ...

Kenya Profile Updated

Jul 2, 2024 - The Kenya profile in ClinRegs has been reviewed and updated with the following information:Minor revisions to the Pharmacy and Poisons Board (PPB) guidance for the conduct of clinical trials, including an updated definition of investigational product, name change for the PPB clinical trial ...