Objectives

To identify the current perspective of the FDA Ghana in the implementation of Good Review Practices, provide a baseline on the knowledge, attitudes, practices, as well as identify areas for enhancement and determine how these procedures relate to continuous process improvement within the FDA Ghana.

Methods

Twenty-seven out of 30 reviewers (90%) of marketing authorisation applications for pharmaceutical products completed a questionnaire developed by the Centre for Innovation in Regulatory Science (CIRS) for the assessment of Good Review Practices.

Results

Good Review Practices (GRevPs) include standard operating procedures, assessment templates, target timelines, quality policies, quality department, internal quality audit, feedback from companies/sponsors, feedback from staff/assessment teams, feedback from patients, ability to track the review process and summary of the basis of the review decision. According to 19 out of 27 (70%) of the reviewers, GRevPs have been developed and fully adopted by the agency. Reviewers provided details indicating reasons why they believe quality measures had been developed within the FDA Ghana. The three most common reasons were to be more efficient, ensure consistency and to minimize errors. Additional training to learn and understand how GRevPs are to be used and incorporated into daily work were indicated as of value. The reviewers acknowledged that the development of Good Review Practices help to improve the quality, management, consistency, efficiency through standardization, transparency, clarity throughout the review process including critical review, decision activities, conflict or dispute resolution and the timeliness of the review process. In this study, the strategies and measures that are in place within the FDA Ghana for developing and maintaining the quality in the review processes have been assessed. The results provide valuable insights into the reviewers of the FDA Ghana, and a baseline has been established regarding the current knowledge, practices, and attitudes within the agency together with an understanding of the contribution of existing processes and procedures that support GRevPs for their continuous improvement. The knowledge base of the FDA Ghana with respect to the role and purpose of Good Review Practices was rated as good, and this serves as the foundation of implementing GRevPs and impacts the practices and attitudes of staff of the agency. The FDA Ghana may therefore consider building a solid GRevP system into its regulatory review process.

Conclusion

In general, the importance of GRevPs is well understood by the respondents, however this study showed that target timelines are not well followed either by the department or agency. This gap has adverse implications regarding patients’ access to medicines. It is hoped that the FDA Ghana will take the necessary steps to address the gaps that have been identified in this study in order to have an improved regulatory review system. This study has evaluated Good Review Practices and their implementation within the FDA Ghana. It has provided a baseline for the FDA Ghana’s knowledge, attitudes and practices as well as areas for improvement. As a result of having a baseline it is possible now to work towards achieving an improvement in the regulatory performance of the FDA Ghana as it moves to become a WHO listed agency.
The following recommendations were identified from this study:
  • Formalise the full implementation of Good Review Practices within the agency which would continue to build quality into the review process to achieve a consistent, predictable, transparent and timely regulatory review.
  • Involve patient advocacy groups in regulatory review activities.
  • Make provisions to include feedback from pharmaceutical manufacturers in regulatory review activities.
  • Improve the transparency and consistency of the scientific review system by implementing a structured framework for decision making and benefit-risk assessment.
  • Enhance transparency and communication through the development of summaries of the basis of approval that may be made available in the public domain.

This poster by Mercy Owusu-Asante was presented at the 2025 DIA Global Annual Meeting, 16-20 June 2025, Washington DC, USA.

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