Ghana’s FDA Moves Toward WHO Listing Amid Strong Systems and Notable Practice Gaps

FDA Ghana has made significant progress in establishing good review practices, but key gaps, especially in timelines, process tracking, and stakeholder feedback—must be addressed to meet WHO-listed authority standards. The study highlights strong foundations, growing capacity, and clear opportunities to further strengthen regulatory performance.

A collaborative study by the University of Hertfordshire, the Food and Drugs Authority (FDA) Ghana, and the Centre for Innovation in Regulatory Science (CIRS) provides one of the clearest portraits yet of how Ghana’s national regulator is strengthening its review systems as it strives to become a World Health Organization-Listed Authority (WLA). Since achieving WHO maturity level 3 in 2020, FDA Ghana has been recognized as a well-functioning agency. But to attain WLA status, it must go beyond having systems in place and demonstrate that good review practices, GRevPs, are embedded in everyday decision-making. Through detailed questionnaires from 27 assessors, the study reveals both the agency’s impressive groundwork and the challenges still ahead.

Foundations of Quality, Strong but Uneven

A large majority of assessors, 70 percent, reported that GRevPs are already fully implemented across the authority. Their reasons were clear: GRevPs improve efficiency, bring consistency to scientific reviews, and reduce errors, all of which are essential for credible regulatory decisions. Yet fewer reviewers identified transparency, communication, or predictability as drivers of quality measures, even though these are key benchmarks used by WHO. This signals that while the structural elements of GRevPs are firmly in place, such as guidelines, templates, and SOPs, the deeper cultural elements that shape accountability and stakeholder trust are still developing.

Implementation in Practice

On paper, FDA Ghana appears to have adopted GRevPs through formal channels: 88 percent of assessors cited standard operating procedures, structured training, and compliance monitoring as the backbone of implementation. Reviewers confirmed that updated documents are accessible and archived, and that training programs support new staff. Still, 60 percent believed the authority lacks a strong mechanism to ensure consistent application. Instead, follow-through depends on supervisory mentoring and individual initiative, a fragile approach that may not sustain the predictability and traceability demanded of a future WLA. The absence of a reliable system for tracking review progress further undermines the authority’s ability to enforce compliance with key timelines.

Where the Gaps Lie

Among all identified gaps, target timelines stood out as the most critical weakness. Reviewers expressed concern that timelines are not consistently followed, largely because tracking tools are inadequate. This shortcoming has real-world consequences: delayed reviews translate into delayed patient access to essential medicines. Feedback loops were another major deficiency. Most assessors said structured feedback from patients, manufacturers, and internal teams is insufficient or absent, despite global regulatory trends that increasingly place stakeholder input at the heart of decision-making. Even so, attitudes toward improvement were overwhelmingly positive. Ninety-three percent of assessors were satisfied with the implementation process so far, but almost all believed the framework requires strengthening. Many called for more frequent, practical training on GRevPs and clearer responsibilities for applying them in daily work.

Roadmap to a WHO-Listed Future

The study’s recommendations signal a clear roadmap for Ghana’s regulatory evolution. The authors urge the authority to formalize GRevP implementation across all departments, ensuring that quality becomes a consistent behavioral norm rather than a procedural intention. They call for structured involvement of patient groups and pharmaceutical companies in the review process, integration of strong feedback systems, expanded training opportunities, and periodic institutional monitoring of GRevP adherence. These steps, together with improved tracking tools and strict enforcement of timelines, would help FDA Ghana align with global standards and prepare for WLA designation. Despite its gaps, the authority’s strong quality policy, clear SOPs, and motivated workforce provide an encouraging foundation. With strategic reforms focused on consistency, transparency, and stakeholder engagement, FDA Ghana is well-positioned to strengthen its regulatory performance and elevate itself to the ranks of WHO-listed agencies.