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S134: Evaluation of the Regulatory Review Process of the FDA Ghana: Challenges and Opportunities for Improvement

Poster Presenter

Mercy Acquaye Owusu-Asante

Graduate Student, School of Life and Medical Sciences
University of Hertfordshire
United Kingdom

Objectives

To assess the regulatory review process of the FDA Ghana from 2019 to 2021 by identifying key milestones, target timelines, good review practices, quality decision-making practices as well as challenges and opportunities for improvement.

Method

In 2022, the FDA Ghana completed the Optimising Efficiencies in Regulatory Agencies (OpERA) questionnaire and provided data identifying the key milestones and overall approval times for medicines and vaccines registered by the FDA Ghana from 2019-2021.

Results

The FDA Ghana conducts full review of quality, safety and efficacy data for new active substances (NASs) and generics which have not been reviewed by the World Health Organization (WHO) or a reference agency, an abridged review for products previously approved by a stringent regulatory authority, and verification review for WHO prequalified products under the collaborative registration procedure. There was an increase in the median approval times for the full review of NASs from 70 to 466 calendar days over the three-year period while the median abridged review times ranged from 84 to 311 calendar days illustrating the impact of reliance. Ninety-one percent of the NASs approved from 2019 to 2021 were biologicals and were processed by the full review or abridged review pathways These increases were due to the impact of the pandemic although the approval times for processing these NASs met the target timelines. Ninety-seven percent of generics approved from 2019 to 2021 were pharmaceuticals and these were also processed by the full review pathway. This increased from 145 products in 2019 to 322 in 2021. However, the median full review times, remained constant with 157, 175 and 136 calendar days for 2019, 2020 and 2021, respectively. The successive annual increase in the number of products registered from 2019 to 2021 was largely due to the 80% reduction of application fee for marketing authorisation introduced in January 2020. A verification fee of 0.80% of the CIF (Cost, Insurance and Freight) value was introduced for imported products. Applicants preferred this option since they only had to pay a comparatively small application fee at the time of applying for marketing authorisation and then pay the verification fee when importing each consignment of the product. Guidelines, standard operating procedures and review templates were in place and the majority of indicators for good review practices were implemented as well as quality decision-making practices.

Conclusion

The FDA Ghana monitors its regulatory performance and currently meets its target timelines. The authority employs the three established regulatory review models for assessing marketing authorisation applications. The extent to which quality, safety and efficacy data are assessed depends on the review model. The first and final milestones in the review process are the receipt of the application and the registration approval date. Currently, there is not as yet an electronic tracking system in place and therefore the obvious challenges associated with a manual system are evident in the data collection processes. The following recommendations for FDA Ghana were identified from the study: • Product-specific guidelines should be provided to help applicants comply with the registration requirements and obtain approval after one review cycle. • An electronic tracking system should be implemented to enable the authority and applicants to track both scientific assessments and applicant’s response time for marketing authorisations. • Annual training workshops should be arranged for manufacturers to help them with submission of fully completed dossiers to facilitate the review process and decrease approval timelines. • Efficient ways should be explored to review marketing authorisation applications for NASs that are assessed via the full review pathway. • A comparison with other stringent regulatory authorities should be carried out to identify best practices. • Public assessment reports for all marketing authorisation applications should be made available. • A systematic and a well-structured quality decision-making practice framework should be implemented. • The timelines for review and decision on a product should be established in terms of both the agency and the industry time These recommendations when implemented will support the agency’s ambition to achieve WHO GBT Maturity Level-4 status as well as being adopted by agencies who share similar ambitions.