Updates | ClinRegs

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. ...

ClinRegs Content and Functionality Upgrades

Dec 8, 2022 - To provide a better user experience and make information easier to find, we have made the following changes to ClinRegs: Revised several topic sections in the left-hand navigation bar on country profiles Made the Share, Comment, and Print options easier to see and use Put the Search ...

China Profile Updated

Nov 18, 2022 - The China profile in ClinRegs has been reviewed and updated with the following information: New guidelines for protocol changes during drug clinical trials (See Scope of Review, Submission Process, and Risk & Quality Management) Several new quality management and technical guidelines ...

Sierra Leone Profile Updated

Oct 31, 2022 - The Sierra Leone profile in ClinRegs has been reviewed for accuracy and updated with the following information: New good clinical practice guidelines for drug trials involving human participants, which was incorporated throughout the profile Updated Pharmacy Board of Sierra Leone (PBSL) ...

Australia Profile Updated with Revised Fees Document

Oct 7, 2022 - The Australia profile in ClinRegs has been updated to include a revised version of the Therapeutic Goods Administration’s fees guidelines effective October 1, 2022. No revisions were made to the requirements described in the guidelines. Sources Revised During this Update: (Guidance) ...

Zimbabwe Profile Updated with Revised Fees Document

Oct 5, 2022 - The Zimbabwe profile in ClinRegs has been updated with the following information: Updated Medicines Control Authority of Zimbabwe (MCAZ) circular regarding application fees for clinical trials, licensing, import and export, and inspection (See Regulatory Fees) Sources ...

Tanzania Profile Updated with Revised Safety Reporting and Inspection Guidelines

Oct 4, 2022 - The Tanzania profile in ClinRegs has been updated to include revised versions of the Tanzania Medicines and Medical Devices Authority’s (TMDA) guidelines related to safety reporting and GCP/GCLP inspection. These guidelines were updated to reflect the change of the former ...