Tanzania Profile Updated with Revised Safety Reporting and Inspection Guidelines

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 Tanzania Food and Drug Administration (TFDA) to the TMDA as per the Financial Act of 2019. No revisions were made to the requirements described in the guidelines. 

Sources Revised During this Update:

(Guidance) Guidelines for Reporting Safety Data in Clinical Trials (G-ReptSafetyData) (2nd Edition) (November 2020)
Tanzania Medicines and Medical Devices Authority

(Guidance) Guidelines for Conducting Good Clinical Practice (GCP) and Good Clinical Laboratory Practices (GCLP) Inspection (G-GCPInspections) (2nd Edition) (November 2020)
Tanzania Medicines and Medical Devices Authority