Updates | ClinRegs

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 ...

Malawi Profile Updated

Sep 8, 2022 - The Malawi profile in ClinRegs has been reviewed for accuracy and updated with the following information: A new checklist of Pharmacy and Medicines Regulatory Authority (PMRA) requirements for submitting a clinical trial application (See Submission Process and Submission Content) PMRA ...

Tanzania Profile Updated

Aug 30, 2022 - The Tanzania profile in ClinRegs has been reviewed and updated with the following information: Updated COSTECH National Research Registration and Clearance guidance (See Regulatory Authority and Clinical Trial Lifecycle) New COSTECH Frequently Asked Questions on applying for a research ...

Guinea Profile Updated

Aug 24, 2022 - The Guinea profile in ClinRegs has been reviewed and updated with the following information: Legislation defining the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM))’s drug registration, authorization, and importation oversight ...

Australia Profile Updated with Revised Fees Document and GCP Inspection Guidance

Aug 23, 2022 - The Australia profile in ClinRegs has been updated with the following information: Updated Therapeutic Goods Administration (TGA) document regarding fees for the evaluation of unapproved medicines and biologicals (See Regulatory Fees) New guidance on the TGA’s Good Clinical Practice ...