Updates
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 ...
South Africa Profile Updated
Sep 26, 2022 - The South Africa profile in ClinRegs has been reviewed for accuracy and updated with the following information:
Updated SAHPRA contact information (See Regulatory Authority)
Updated application to conduct a clinical trial and updated application for a protocol amendment to an approved ...
Mali Profile Updated
Sep 15, 2022 - The Mali profile in ClinRegs has been reviewed for accuracy and updated with the following information:
Regulations related to the establishment and member appointment of the Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University of Sciences, Techniques ...
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