Updates | ClinRegs

India Profile Updated

Feb 2, 2023 - The India profile in ClinRegs has been reviewed and updated with the following information: New amendment to the New Drugs and Clinical Trials Rules which provides the timelines for when ethics committee registration, clinical trials, investigational product manufacturing, and active ...

Guinea Profile Updated

Jan 27, 2023 - The Guinea profile in ClinRegs has been reviewed and updated with the following information: The National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM)) has been renamed to the National Directorate of Medicines and Pharmacies ...

US Profile Updated

Jan 19, 2023 - The United States profile in ClinRegs has been reviewed and updated with the following information: More detailed descriptions of Food & Drug Administration (FDA) and institutional review board (IRB) clinical trial review processes (See Scope of Assessment and Scope of Review) Supplementary ...

UK Profile Updated

Jan 13, 2023 - The United Kingdom profile in ClinRegs has been reviewed for accuracy and updated with the following information: Updates to the combined review processes for clinical trials (See Scope of Assessment and Clinical Trial Lifecycle topic) Updated information about the UK Research Ethics ...

Liberia Profile Updated with ACRE IRB Handbook

Dec 22, 2022 - The Liberia profile in ClinRegs has been updated to include the following: Revised fees for the Atlantic Center for Research and Evaluation Institutional Review Board (ACRE IRB) (see Ethics Committee Fees) Updated references to the ACRE IRB Policies and Procedures ...

Peru Profile Updated

Dec 21, 2022 - The Peru profile in ClinRegs has been reviewed for accuracy and updated with the following information: Regulations and resources on personal data protection and treatment of health-related personal data (See Personal Data Protection) New INS virtual submission platform and related ...

Brazil Profile Updated with Amendment to Rare Diseases Resolution

Dec 13, 2022 - The Brazil profile in ClinRegs has been updated to include RDC No. 763, of November 25, 2022, which amends RDC No. 205, of December 28, 2017. A pre-submission meeting related to an application to conduct a clinical trial of a rare disease is now only required if deemed necessary by the applicant. ...