• Manoj Swaminathan

Pharmacovigilance - Interesting facts about FDA Ghana

Updated: Aug 11


Ghana joined the WHO International Drug Monitoring Program in November 2001 as the 65th member of the program and the first country from West Africa to get enrolled.


Ever since the Pharmacovigilance guidelines have well evolved. These guidelines are even updated from time to time.


The MAH is required to report domestic serious reports within 7 calendar days. There is a need to have a qualified person for Pharmacovigilance in place. FDA Ghana has a guideline for conducting Pharmacovigilance Inspections. From time to time, FDA Ghana even publishes the List of Marketing Authorization holders (MAH) who have undergone good Pharmacovigilance Practice Inspections. Like many other countries, Ghana also faces the problem of under-reporting.


FDA Ghana even trains healthcare personnel on Pharmacovigilance. The FDA has an online safety database called as SafetyWatch System (SWS) which is ICH E2B. The Case-reports are sent to the WHO International Drug Monitoring Program as an E2B XML files.


FDA Ghana even publishes list of operational guidelines for Pharmaceutical products.

Besides, Ghana also has the following list of Pharmacovigilance guidelines: