Tanzania Profile Updated
The Tanzania profile in ClinRegs has been reviewed and updated with the following information:
- The Tanzania Medicines and Medical Devices Authority (TMDA) six-month progress report form for clinical trials of an investigational product (See Progress Reporting)
- Information on the TMDA’s Clinical Trials Control and Pharmacovigilance Section (See Regulatory Authority and Scope of Assessment)
- TMDA guidelines from 2021 related to the importation and exportation of pharmaceutical products and raw materials (See Manufacturing & Import)
- National Institute for Medical Research (NIMR) guidelines from 2022 for the National Health Research Ethics Committee (NatHREC)’s review of health research protocols (See Scope of Review and Submission Content)
- Tanzania Commission for Science and Technology (COSTECH) guidelines from 2020 related to research integrity and ethics review (See Ethics Committee, Scope of Review, Oversight of Ethics Committees, Submission Process, and Submission Content)
Sources Added During this Update:
(Guidance) Guidelines for Importation and Exportation of Pharmaceutical Products and Raw Materials (G-ImpExp) (Fourth Edition) (January 2021)
Tanzania Medicines and Medical Devices Authority
(Guidance) Guidelines for Reviewing Health Research Protocols (G-RevPrtcl) (July 2022)
National Institute for Medical Research
(Guidance) National Research Integrity Framework of Tanzania (G-ResearchIntegrity) (First Edition) (2020)
Tanzania Commission for Science and Technology
(Form) Six Monthly Progress Report for Clinical Trial of an Investigational Medicinal Product (TZA-3) (Date Unavailable)
Tanzania Medicines and Medical Devices Authority
(Webpage) Clinical Trials Control and Pharmacovigilance – Section Profile (TZA-2) (Current as of April 20, 2023)
Tanzania Medicines and Medical Devices Authority
Sources Revised During this Update:
(Guidance) Guidelines for Application to Conduct Clinical Trials in Tanzania (G-AppConductCT) (Revision 4) (March 2020)
Tanzania Medicines and Medical Devices Authority