The regulatory framework for clinical trials in Tanzania is robust, involving multiple layers of oversight to ensure ethical standards and participant safety:

• Tanzania Medicines and Medical Devices Authority (TMDA): Main authority responsible for authorization, oversight, and inspection of clinical trials, established under the Tanzania Medicines and Medical Devices Act, 2003 (Cap 219).
• National Institute for Medical Research (NIMR) through the National Health Research Ethics Committee (NHREC): Reviews and grants ethical clearance for all clinical trials prior to TMDA approval. Local Institutional Review Boards (IRBs) support this process by ensuring cultural and contextual considerations are addressed.
• Tanzania Commission for Science and Technology (COSTECH): Provides permits for foreign investigators and ensures alignment of externally led trials with national priorities.
• Chief Government Chemist Laboratory Agency (GCLA): Regulates human DNA research, including laboratory registration and oversight of the national DNA database.
• The Minister of State in the President’s Office-Regional Administration and Local Government (PO-RALG): Provides permits for working in the local authorities/areas.

To enhance efficiency, Tanzania has adopted digital platforms:

• National Research Ethics Information Management System (NREIMS): An online system for submission, evaluation, and tracking of ethical clearance applications.
• Regulatory Information Management System (RIMS): Used by TMDA to process, track, and approve clinical trial applications.

Approval timelines are guided by client service charters and harmonized with African Vaccine Regulatory Forum (AVAREF) standards:

• NHREC: 6–8 weeks for standard review; 4 weeks for expedited review.
• TMDA: 60 working days for normal review; 30 working days for expedited review.   

Despite progress, challenges remain, particularly in funding sustainability, limited trained personnel, and occasional delays in review timelines. Nonetheless, Tanzania continues to strengthen its clinical trial ecosystem through Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) inspections, transparent fee structures, and regional alignment.