Assessment of the effectiveness and efficiency of the West Africa medicines regulatory harmonization initiative by the member countries

Owusu-Asante, Mercy; Darko, Delese Mimi; Walker, Stuart; Salek, Sam

doi:10.3389/fphar.2022.1069345

Cited by 7 publications

(16 citation statements)

References 2 publications

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“…Some of the challenges of the ECOWAS-MRH initiative namely, lack of centralised submission and tracking which were identified by the applicants in the study were also identified by the NMRAs in the previous study ( Owusu-Asante et al, 2022 ). Similar to the studies conducted with regard to the EAC-MRH and ZaZiBoNa ( Ngum et al, 2022 ; Sithole et al, 2022 ), these challenges were also reported with regard to the respective regional MRH initiatives.…”

Section: Discussionmentioning

confidence: 92%

“…Started in 2017 by the West African Health Organization (WAHO), the ECOWAS-MRH initiative seeks to enhanced accessibility of high-quality, safe and effective medicines and vaccines in the ECOWAS ( Owusu-Asante, 2022 ). By the joint registration of both local and imported medical products, this programme seeks to expedite registration and advance regulatory processes ( Daniel, 2019 ).…”

Section: Introductionmentioning

confidence: 99%

“…As of 2023, seven NMRAs take part in initiative sessions: Burkina Faso, Cote d’Ivoire, Ghana, Nigeria, Senegal, Sierra Leone and Togo. Whilst only these seven countries take part in the joint assessments, the results of the assessments form the foundation for regulatory decisions in all 15 ECOWAS NMRAs ( Owusu-Asante, 2022 ). Using a rotational system, the ECOWAS-MRH appoints one country to act as lead NMRA/coordinator for 2 years and acts as the coordinator for product applications.…”

Section: Introductionmentioning

confidence: 99%

“…As a result of completing an earlier study aimed to assess the effectiveness and efficiency of the current operating model of the ECOWAS-MRH initiative by the national medical regulatory authorities (NMRAs) in the member countries ( Owusu-Asante et al, 2022 ), this present study aimed to assess the effectiveness and efficiency of the ECOWAS-MRH initiative by the pharmaceutical industry in order to obtain a holistic view of the current status of the initiative.…”

Section: Introductionmentioning

confidence: 99%

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Assessment of the effectiveness and efficiency of the economic community of West African States Medicines Regulatory Harmonization initiative by the pharmaceutical industry

Owusu-Asante

Darko²,

Walker

et al. 2023

Front. Pharmacol.

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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.

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Section: Discussionmentioning

confidence: 92%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Assessment of the effectiveness and efficiency of the economic community of West African States Medicines Regulatory Harmonization initiative by the pharmaceutical industry

Owusu-Asante

Darko²,

Walker

et al. 2023

Front. Pharmacol.

Self Cite

View full text Add to dashboard Cite

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“…In addition, the Steering Committee for ECOWAS regional regulatory harmonisation initiative finalised its regional joint assessment procedure in 2019. The process gives a single filing offering access to the 350 million population of ECOWAS [ 14 , 15 ].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Risk-Based Approaches to the Registration of Medicines: Current Status Among African Regulatory Authorities

et al. 2023

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Background Despite the worldwide need for increased access to safe and effective medicines, there is a lack of innovative medicines in many low- to middle-income countries. On the African continent, this is partly due to capacity limitations of National Regulatory Authorities (NRAs). One important approach to address this issue is work sharing and regulatory reliance. Therefore, the aim of this study of regulatory authorities on the African continent was to identify which risk-based approaches are being used as well as their foreseen role in the future. Methods The study employed a questionnaire to identify which risk-based models are used for the regulatory approval of medicines and to determine which frameworks are in place to enable a risk-based approach, as well as to provide insight into the future direction for risk-based models. The questionnaire was sent electronically to 26 NRAs in the African Continent. Results Twenty-one authorities (80%) completed the questionnaire. Work sharing was the most commonly used model, followed closely by unilaterial reliance, information sharing, and collaborative review. These methods were perceived to be an effective and efficient use of resources, enabling faster medicine availability for patients. The unilateral reliance approach by the authorities included abridged (85%), verification (70%) and recognition (50%) models for a range of products. However, challenges included a lack of guidelines to undertake a reliance review together with resource constraints, while access to assessment reports was the most common barrier to using a unilateral reliance model. Conclusions Many authorities in Africa have adopted a risk-based approach to medicines registration and created work sharing, unilateral reliance pathways and regionalisation models to facilitate the availability of medicines. The authorities believe that in future, assessment routes should move from stand-alone reviews to risk-based models. However, this study indicated that there would be challenges to implement this approach in practice, which would include improving resource capacity and the number of expert reviewers as well as implementing electronic tracking systems. Supplementary Information The online version contains supplementary material available at 10.1007/s40290-023-00472-0.

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Regional regulatory harmonisation initiatives: Their potential contribution to the newly established African Medicines Agency

Ngum,

Ndomondo-Sigonda,

Walker

et al. 2023

Regulatory Toxicology and Pharmacology

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Assessment of the effectiveness and efficiency of the West Africa medicines regulatory harmonization initiative by the member countries

Cited by 7 publications

References 2 publications

Assessment of the effectiveness and efficiency of the economic community of West African States Medicines Regulatory Harmonization initiative by the pharmaceutical industry

Assessment of the effectiveness and efficiency of the economic community of West African States Medicines Regulatory Harmonization initiative by the pharmaceutical industry

Evaluation of Risk-Based Approaches to the Registration of Medicines: Current Status Among African Regulatory Authorities

Regional regulatory harmonisation initiatives: Their potential contribution to the newly established African Medicines Agency

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