With support from the Pandemic Influenza Preparedness Framework Partnership Contribution (PIP PC), Ghana has developed a well-functioning regulatory system for medical products that has proved critical in enabling the country’s response to COVID-19.

A regional milestone

In April 2020, after being assessed by WHO using the Global Benchmarking Tool, the Food and Drug Authority (FDA) of Ghana was found to meet all indicators that define a maturity level 3 (ML3) agency. In doing so, it became the second confirmed country in Africa to achieve a stable, well-functioning and integrated regulatory system for medical products.

The achievements of FDA Ghana and FDA Tanzania (the other ML3 agency in Africa) mark a milestone for the region and open the door for stakeholders across Africa to work collectively for timely access to quality assured medical products. Their success was enabled by years of system strengthening investment, action and support, including support from PIP PC to build staff capacity and develop regulatory tools in areas such as pharmacovigilance, market control, marketing authorization and clinical trials oversight. 

Securing supplies

In the face of COVID-19, FDA Ghana’s investment in regulatory system strengthening has been very beneficial. The agency has been a key enabler of the Ministry of Health’s pandemic response. For example, by providing timely support to local industry, FDA Ghana ensured the availability of affordable and quality-assured personal protective equipment during the pandemic, including the hand sanitizers and face masks that were at the heart of safety protocols for controlling COVID-19 infections. FDA Ghana’s capacity to quickly develop specifications and guidance, and to establish a fast-track for marketing authorization, enabled the country to secure vital supplies at a time of acute scarcity across the region.

At the same time, FDA Ghana made use of strategies such as working from home, electronic submissions, online reviews and virtual meetings and inspections to continue performing its routine regulatory activities.

Deploying vaccines

FDA Ghana’s capacity as a ML3 agency is also proving its worth as the country prepares to deploy COVID-19 vaccines. Ghana is the first country outside India to receive vaccines through the COVAX facility; and FDA Ghana is using its full capabilities to ensure these can be rapidly and effectively approved, received, distributed and administered. The agency has, for example, already activated its Emergency Use Authorization Procedure to review submissions for the various candidate vaccines.

Ghana has long seen the value of strengthening its regulatory system. Building on its success during the COVID-19 pandemic, it remains committed to continuous improvement in preparation for the next influenza pandemic.

Photo caption: FDA Ghana has secured vital supplies of hand-sanitizers and other personal protective equipment during the COVID-19 pandemic.

Photo credit: WHO/Blink Media - Nana Kofi Acquah