Eight years of the East African Community Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned

Mashingia, Jane; Ahonkhai, Vincent I.; Aineplan, Noel; Ambali, Aggrey; Angole, Apollo; Arik, Mawien; Azatyan, Samvel; Baak, Peter; Bamenyekanye, Emmanuel; Bizoza, Aimable; Chamdimba, Chimwemwe; Doerr, Petra; Fimbo, Adam M.; Gisagara, Alex; Hamad, Hidaya; Harris, Rachelle; Hartman, Dan; Kabatende, Joseph; Karangwa, Charles; Kijo, Agnes Sitta; Maboko, Shani; Matle, David; Muhairwe, Apollo; Mwesigye, John Patrick; Nyabenda, Bonaventure; Schulze, Alexander; Seiter, Andreas; Sematiko, Gordon; Sigonda, Margareth; Sillo, Hiiti; Simai, Burhani; Siyoi, Fred; Sonoiya, Stanley; Tanui, Paul; Ward, Monika A.; Yano, Felistas; Mukanga, David

doi:10.1371/journal.pmed.1003134

Cited by 26 publications

(53 citation statements)

References 3 publications

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“…This is a much more attractive prospect than the lengthy wait time that companies previously experienced [13]. Since the EAC MRH initiative's joint assessment program launched in 2015, it has received 93 product applications (and assessed 83 of them)-a solid start but one suggesting that the process has yet to be fully embraced by industry [3]. The program's attractiveness to users may be limited by its apparent inability to meet target timelines.…”

Section: Rarely Usedmentioning

confidence: 99%

“…The program's attractiveness to users may be limited by its apparent inability to meet target timelines. For example, many EAC partner states are not registering jointly approved products within the advertised 3-month period [3]. An agreement by which all partner states are required to abide by joint assessment decisions would minimize this problem.…”

Section: Rarely Usedmentioning

confidence: 99%

“…The EAC MRH initiative is already tracking time from application receipt to approval, or total assessment time [3]. By continuing to define target timelines for key milestones in the joint assessment process, developing formal processes for routinely monitoring relevant metrics, and making the resulting data public [21], the EAC MRH initiative can increase its efficiency and promote trust among stakeholders.…”

Section: Best Practices For Regulatory Reliancementioning

confidence: 99%

“…In the final article in this Special Collection in PLOS Medicine about the East African Community (EAC) Medicines Regulatory Harmonization (MRH) initiative [1][2][3][4], we, a group of authors who have had no involvement in the EAC MRH's work to date, provide an independent perspective on the program's work thus far and its plans for the future. The initiative's goal is to improve access to essential medicines in East Africa by simplifying the process of registering medicines and increasing the speed at which registration applications are reviewed while ensuring that only high-quality medicines are approved.…”

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confidence: 99%

“…Dr Grignolo then invited us to contribute, as a team of coauthors with rich and varied experience in regulatory harmonization. We were provided with drafts of the other articles in the Special Collection [1][2][3][4], but otherwise, this perspective was written without input or influence from the other authors or from the EAC MRH initiative or its partners, including the Bill & Melinda Gates Foundation. Information about each author's background can be found in S1 Text.…”

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confidence: 99%

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Improving access to quality medicines in East Africa: An independent perspective on the East African Community Medicines Regulatory Harmonization initiative

Giaquinto¹,

Grignolo

Liberti

et al. 2020

PLoS Med

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• The goal of improving access to quality medicines in East Africa has been addressed by the East African Community (EAC) Medicines Regulatory Harmonization (MRH) initiative, which is working to simplify the process of registering medicines and increase the speed at which registration applications are reviewed while ensuring that only highquality medicines are approved. • This article was written by a group of authors with varied expertise in global regulatory affairs but no involvement to date in the EAC MRH initiative. The authors were asked to provide an independent perspective on the initiative's work since its launch in 2012, as well as its plans for the future.

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Section: Rarely Usedmentioning

confidence: 99%

Section: Rarely Usedmentioning

confidence: 99%

Section: Best Practices For Regulatory Reliancementioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Improving access to quality medicines in East Africa: An independent perspective on the East African Community Medicines Regulatory Harmonization initiative

Giaquinto¹,

Grignolo

Liberti

et al. 2020

PLoS Med

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Assessment of pharmacovigilance guidelines in the Southern African Development Community: A document review

Makhene,

Steyn,

Vorster

et al. 2024

Pharmacoepidemiology and Drug

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BackgroundLack of harmonization in pharmacovigilance (PV) practice in resource‐limited states in Africa has led to differentiation and marginalization, thus creating an environment where weak or absent PV systems may benefit from regional guidelines.PurposeTo compare the PV guidelines of Southern African Development Community (SADC) member states to international guidelines and identify areas for improvement for aligning PV practice within the SADC region.MethodsWe utilized a 73‐item checklist to assess the PV guidelines of the SADC member states. Checklist parameters were rated using binary scoring.ResultsOnly seven (Botswana, Mauritius, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe) of the 16 SADC member states had guidelines to assess. Of these, only four had supporting legislation. All seven national medicines regulatory authorities (NMRA)'s guidelines required reporting of local serious adverse drug reactions (ADRs). Four NMRAs implemented device vigilance; none specified submission timelines for ADRs associated with substandard or falsified medicines. Only three NMRAs required electronic transmission of individual case safety reports in the E2B format. Five NMRAs mandated safety monitoring during interventional clinical trials. Five NMRAs required aggregate reporting through periodic safety update reports. Only two NMRAs required submission of the development safety update report. Regarding risk management, four NMRAs required notification of actions taken by foreign NMRAs and four NMRAs expected to review Dear Healthcare Professional Letters before distribution by the marketing authorization holder.ConclusionsAreas for improvement of guidelines to establish common process standards and allow for synchronized submissions of comparable data to SADC NMRAs are provided.

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Medicines Regulatory Science Expertise in Africa: Workforce Capacity Development and Harmonisation Activities Towards the Establishment of the African Medicines Agency

2022

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The medicines regulatory landscape in Africa is undergoing transformation with at least two countries having National Medicines Regulatory Authorities (NRAs) that operate at World Health Organization (WHO) maturity level 3. However, this represents the exception as over 90% of African NRAs have limited capacity to perform core medicine regulatory functions, have a shortage of competent regulatory professionals, have high staff turnover, lack diversity of scientific expertise, and have staffing shortages relative to the high workload. A systematic approach to developing the regulatory workforce is therefore crucial to addressing the existing shortfalls in regulatory capacity, particularly at this time when efforts are underway to operationalise the African Medicines Agency (AMA). In this article, initiatives that are building African NRAs' regulatory capacity and developing their workforce are reviewed in preparation for work to be conducted by the AMA. We found that the African Medicines Regulatory Harmonisation (AMRH) initiative has been at the forefront of capacity building and workforce development mainly through the designation of specialised Regional Centres of Regulatory Excellence and the implementation of medicines regulatory harmonisation initiatives in regional economic communities. In addition, some NRAs within high-income countries and trusted institutions have been supporting regulators in low-income countries with registration assessments and facilitating access to quality-assured medical products through their stringent review procedures (SRPs). Capacity building has subsequently been facilitated through this active involvement of African regulators in SRPs. This article also provides recommendations for further capacity building and workforce development.

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Eight years of the East African Community Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned

Abstract: • Access to essential medicines is a key pillar of any health system seeking to deliver universal health coverage. Science-based, independent regulation of medical products is a critical part of ensuring that only quality essential medicines reach the patients who need them.

Cited by 26 publications

References 3 publications

Improving access to quality medicines in East Africa: An independent perspective on the East African Community Medicines Regulatory Harmonization initiative

Improving access to quality medicines in East Africa: An independent perspective on the East African Community Medicines Regulatory Harmonization initiative

Assessment of pharmacovigilance guidelines in the Southern African Development Community: A document review

Medicines Regulatory Science Expertise in Africa: Workforce Capacity Development and Harmonisation Activities Towards the Establishment of the African Medicines Agency

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