Tanzania Outlines Devicemaker Obligations in Clinical Trials

The Tanzania Food and Drugs Authority (TFDA) requires formal reports for serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR) in clinical trials conducted in the country, according to a draft guideline for sponsors, investigators and contract review organizations. SAEs and SUSARs that occur outside the country for multicenter trials and “other protocol-defined reporting” also should be reported to the TFDA, the draft states.
International Medical Device Regulatory Monitor