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.

More interesting facts (QPPV related):

1. QPPV role in Ghana needs to be a full-time job. The FDA-Ghana reserves the right to withdraw the license of any QPPV who is found to take up full-time role with another company.
2. FDA Ghana has a template contract for QPPV
3. FDA Ghana has designed an application for re-designation as QPPV
4. A non-HCP with a relevant scientific discipline with at least two years minimum experience with specific job function in the area of pharmacovigilance can be designated as the QPPV.