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IntroductionWhen implemented by national and regional regulatory agencies good review practices (GRevPs) support the timely high-quality review of medicines for enhanced patients’ availability to safe, quality and efficacious innovative and generic products. It is important that all aspects of GRevPs are continuously evaluated and updated to promote the continuous improvement of regulatory systems at national and regional levels. The aim of this study was to assess and compare the GRevPs of the national medicines regulatory agencies (NMRAs) of Burkina Faso, Cote d’Ivoire, Ghana, Nigeria, Senegal, Sierra Leone and Togo, who are active participants of the ECOWASMRH initiative to identify opportunities for improvement.MethodsThe Optimising Efficiencies in Regulatory Agencies questionnaire, was completed by each of the NMRAs, which facilitates the assessment of GRevPs, which in turn affect the regulatory review processes.ResultsExcept for Cote d’Ivoire and Nigeria which are autonomous, the other five NMRAs operate within the administrative structure of their respective Health Ministry, to regulate medical products for human use, medical devices and diagnostics. Apart from Togo, the agencies receive partial funding from their governments as well as from regulatory fees. Population in the seven countries ranges from 8.6 million to 211.4 million. All the NMRAs had measures in place to achieve quality in their review processes, although there were some remaining initiatives related to transparency and communication, continuous improvement and training and education, to be implemented. Of the ten quality decision-making practices Ghana had implemented nine into a framework, Togo eight, Cote d’Ivoire seven, Nigeria six, and Burkina Faso five; while Sierra Leone has partially implemented all ten and Senegal had not implemented any of the quality decision-making practices.ConclusionThe study compared the organisation, GRevPs and quality decision-making processes of the NMRAs that actively participate in the ECOWAS-MRH initiative. Though some differences were identified with regard to organisation, a significant number of good review practice initiatives and quality decision-making practices were identified yet to be implemented to promote continuous improvement in the regulatory processes of the NMRAs.

Background The use of mobile phone technology for reporting adverse drug reactions (ADRs) in pharmacovigilance is relatively new. The objective of the study was to explore challenges and facilitators for the use of the Med Safety App for reporting ADRs in Ghana. A comparative evaluation of ADR reports received through the app and the standard paper-based form was also conducted. Methods This was a cross-sectional study with a purposive sampling technique. The study population was persons who had downloaded the Med Safety App launched in Ghana 18 months before the study. Results Of the 350 participants, 121 provided answers to the questionnaire sent as a Google form, representing a response rate of 34.6%. Ninety-five (78.5%) of the participants were healthcare professionals, and the remaining were patients. Seventy-five (64.7%) of the participants were using the app after initial installation because they thought it had helpful features. However, only 33 (27.3%) participants used the app to report ADRs, and of these, seven (21.2%) participants indicated that they would continue to use the app because it was easier than the other means of reporting ADRs. Most of the respondents, 109 (94%), indicated that they would recommend the app to someone else. There were some differences between the reports received through the app and between the paper-based Council for International Organizations of Medical Sciences (CIOMS) 1 form and the app, which warrant further exploration. Conclusion Most participants indicated that the app is a useful tool and easy to use, and they were satisfied with the features of the app. Given that only just under one-third of participants had used the app to report ADRs, more time and training may be required to fully evaluate the feasibility of the use of the app going forward. The findings will help improve introduction of the app in other countries.

Background: Following the establishment of Economic Community of West African States Medicines Regulatory Harmonization (ECOWAS-MRH) initiative in 2017, it was considered timely to carry out an evaluation of the current status of the initiative’s operating model by the pharmaceutical industry users. This study examined the challenges being encountered and identified strategies that would strengthen the ECOWAS-MRH initiative moving forward.Methods: The Process Effectiveness and Efficiency Rating (PEER) questionnaire was used to collect data from manufacturers who have submitted applications to the joint assessment procedure and had identified recommendations for improving the performance of the ECOWAS-MRH initiative.Results: Ten pharmaceutical manufacturer participants (innovator, generic foreign, generic local) all reported that harmonisation of registration requirements was a major benefit, allowing submission of the same dossier to multiple countries, reducing the application burden and saving time and resources. Additionally, receipt of the same list of questions from several countries enables the compilation of a single response package, resulting in shorter timelines for approvals compared to the individualised country responses. Another benefit of a harmonised registration process was the simultaneous accessibility of medicines in various markets. Key challenges included a lack of centralised submission and tracking, differences in regulatory performance of the national medical regulatory authorities, a lack of detailed information for applicants and a low motivation to use the ECOWAS-MRH route with a preference for other regulatory pathways in the ECOWAS member states.Conclusion: This study identified several approaches to increase the effectiveness of this initiative: the implementation of risk-based approaches such as use of reliance pathways; establishment of a robust information technology systems, building assessor capacity to facilitate processing and monitoring applications; and priority review of ECOWAS-MRH products.

BackgroundAdverse Drug Reactions (ADRs) can occur with all medicines even after successful extensive clinical trials. ADRs result in more than 10% of hospital admissions worldwide. In Ghana, there has been an increase of 13 to 126 ADR reports per million population from 2012 to 2018. ADR Surveillance System (ADRSS) also known as pharmacovigilance has been put in place by the Ghana Food and Drugs Authority (FDA) to collect and manage suspected ADR reports and communicate safety issues to healthcare professionals and the general public. The ADRSS in Ho Municipality was evaluated to assess the extent of reporting of ADRs and the system's attributes; determine its usefulness, and assess if the ADRSS is achieving its objectives.MethodsWe evaluated the ADRSS of the Ho Municipality from January 2015 to December 2019. Quantitative data were collected through interviews and review of records. We adapted the updated CDC guidelines to develop interview guides and a checklist for data collection. Attributes reviewed included simplicity, data quality, acceptability, representativeness, timeliness, sensitivity, predictive value positive and stability.ResultsWe found a total of 1,237 suspected ADR during the period, of which only 36 (3%) were reported by healthcare professionals in the Ho Municipality to the National Pharmacovigilance Centre (NPC). Only 43.9% of health staff interviewed were familiar with the ADRSS and its reporting channel. Staff who could mention at least one objective of the ADRSS were 34.2%, and 12.2% knew the timelines for reporting ADR. Reports took a median time of 41 (IQR = 25, 81) days from reporter to NPC. Reports sent on time constituted 37.5%. Fully completed case forms constituted 77.1% and the predictive value positive (PVP) was 20%. About 53% of ADRs were reported for female patients. Up to 88.9% of ADRs were classified as drug related. Anti-tuberculosis agents and other antibiotics constituted (40.6%) and (18.8%) of all reports. The ADRSS was not integrated into the disease surveillance and response system of Ghana's Health Service and so was not flexible to changes. A dedicated ADR surveillance officer in regions helped with the system's stability. Data from Ghana feeds into a WHO database for global decision making.ConclusionsThere was under-reporting of ADRs in the Ho Municipality from January 2015 to December 2019. The ADR surveillance system was simple, stable, acceptable, representative, had a strong PVP but was not flexible or timely. The ADRSS was found useful and partially met its objectives.

Background: The West Africa Health Organization launched the West Africa Medicines Regulatory Harmonization Project (WA-MRH) in 2017 with the overarching objective to improve the availability of high-quality, safe and effective medicines and vaccines by the 15 countries in the Economic Community of West African States region. Although this project has made significant progress towards the realisation of its goals, challenges still remain. The aims of this study were to evaluate the effectiveness and efficiency of the WA-MRH, examine what challenges are being encountered and identify strategies that would strengthen the process for realising the initiative’s goals.Methods: The Process Effectiveness and Efficiency Rating (PEER) questionnaire was used to collect data from assessors representing the seven active NMRAs in the joint assessment procedure that identified the benefits, challenges and recommendations for improving the performance of the WA-MRH project.Results: The benefits of the joint assessment procedure include time savings to manufacturers resulting from submitting one dossier and the same response package to multiple countries resulting in access to the multiple African markets within the same timeframe. Additionally, some of the NMRAs have been able to strengthen their technical capacity as a result of this initiative. Key challenges to the project include the lack of a robust information technology system that would enable dossier tracking and constraints in human resources needed to support dossier submissions and the assessment process.Conclusion: This study identified the strengths of the WA-MRH initiative as well as strategies for improvement and achievement of its objectives. The centralised submission of a dossier and its tracking is key to the regulatory assessment process. This research has demonstrated that amongst other considerations, a robust information technology system, coupled with the necessary human resource capacity would greatly enhance the effectiveness and efficiency of the WA-MRH initiative.