Tanzania

Pharmacovigilance in Tanzania is regulated by the Tanzania Medicines and Medical Devices Authority (TMDA) through its Clinical Trials Control and Pharmacovigilance Section, under the national Pharmacovigilance Regulations. TMDA’s medicines-registration guidance defines the marketing authorisation Holder (MAH) as a person resident or domiciled in Tanzania and responsible for the authorised product. Under the official EAC Harmonized Pharmacovigilance Compendium, MAHs must establish a pharmacovigilance system, appoint a qualified person responsible for pharmacovigilance (QPPV), and maintain an up-to-date PSMF accessible to TMDA upon request. The QPPV must reside within an EAC Partner State, but not necessarily in Tanzania. For local post-marketing reports, fatal cases are due as soon as possible and no later than 7 calendar days, serious non-fatal reactions within 15 calendar days, and non-serious reactions within 30 calendar days. PSURs/PBRERs are generally required every six months for the first two years, annually for the next two years, and every three years thereafter, unless TMDA specifies otherwise. Suspected reactions may be submitted through TMDA’s official reporting channels. Where the cited public sources do not expressly define ICSR reporting route and timelines, risk-management plan, signal management and audit and inspection arrangements, the MAH should confirm the current product-specific requirements with the competent authority and against the marketing-authorisation conditions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.