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Understanding Ghana's FDA and pharmacovigilance regulations

Pharmacovigilance Education for the oncology community in Africa

1 Apr - 28 May 2025

Published: 16 Jun 2025

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Ms. Priscilla Aduse-Poku

Ghana's FDA regulates medical products to ensure safety and effectiveness, requiring local representatives for market authorization.

The Public Health Act 851 of 2012 establishes a legal framework for safety monitoring. Local representatives monitor product safety and report adverse events, while the FDA analyses drug reactions.

Currently, there are no specific pharmacovigilance requirements for anti-cancer medicines, and Market Authorization Holders must appoint qualified persons for pharmacovigilance.

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