Regulatory Spotlight - 10
December 16, 2024
Showcasing the latest developments, news and updates from African national medicines regulatory authorities.
The African Medicines Regulatory Harmonisation (AMRH) initiative was started in 2009 to address challenges faced by national medicines regulatory authorities (NRAs) on the continent. These challenges include, but are not limited to, weak or non-coherent legislative frameworks, lengthy medicine registration processes and subsequent delays in reaching decisions on whether to grant marketing authorisation or not, limited technical capacity and inadequate human resources. These challenges were contributing to poor access to essential medicines in Africa.
The 4th AMRH week was held from 28 October - 1 November 2024 in Maputo, Mozambique to celebrate the 15th anniversary of the initiative. This year’s theme was "15 Years of AMRH as a Foundation for the African Medicines Agency (AMA)”. AMRH week is a biennial meeting organised by the AMRH Joint Secretariat comprising the African Union Development Agency-NEPAD (AUDA-NEPAD) and the World Health Organization (WHO). It served as a platform to review progress made in implementing previous recommendations and advancing regulatory systems across Africa. Specific objectives of the week included reviewing and adopting key technical documents such as continental guidelines, standard operating procedures and templates that support regulatory systems strengthening. In addition, strategies to address substandard and falsified medical products on the continent were discussed. The event also saw the launch of the Regulatory Information Sharing Portal (RISP). Other milestones that were celebrated are the AMA Continental Pilot on Human Medicinal Product Listing (which is evaluating 24 medical product dossiers), the new AMA treaty ratifications from Côte d'Ivoire, Zambia, and Tanzania, and the continent now having six NRAs operating at WHO maturity level 3 (three more NRAs are expected to attain this designation in the next six months).
The Zanzibar Food and Drug Agency hosted the first BREEDIME project annual consortium meeting from 18 – 19 November 2024 to review the progress and implementation of the project which commenced in August 2023. BREEDIME is an acronym for “Building research ethics, diagnostics and medicines regulatory capacity during routine and public health emergency periods”. The main objective of the BREEDIME project is to strengthen regulatory affairs in areas of ethical review processes, clinical trials control, assessment, and post marketing evaluation of therapeutics, vaccines, diagnostics, and critical medical devices. The 36-month project involves nine consortium members, namely the Tanzania Medicines and Medical Devices Authority (TMDA), Karolinska Institutet(KI), Zanzibar Food and Drug Agency (ZFDA), Rwanda Food and Drugs Authority (Rwanda FDA), Kilimanjaro Clinical Research Institute (KCRI) (KCRI-GSF KCMC), Muhimbili University of Health and Allied Sciences (MUHAS), National Institute for Medical Research (NIMR), Zanzibar Health and Research Institute (ZAHRI) and University of St Andrews. Project deliverables, timelines and achievements of the project can be read here.
Fellows of the PharmTrain2 Clinical Assessors Fellowship gathered in Dar es Salaam, Tanzania to advance the joint project focused on development of a comprehensive training manual for African clinical assessors. The focus was specifically on drafting and refining advanced training modules on the evaluation of efficacy and safety studies. The fellows are senior assessors from the Food and Drugs Authority,Ghana, South African Medical Research Council, Tanzania Medicine and Medical Devices Authority and the Medicines Control Authority Of Zimbabwe. The manual, designed to support beginner to intermediate-level assessors from African NRAs, provides structured, sustainable training on the assessment of the clinical components of a dossier. It also includes key clinical and regulatory background knowledge and interactive hands-on exercises.
At the end of this meeting, the fellows welcomed staff from other African NRAs and proceeded to train them at the first continental training on clinical assessment organised by African Union Development Agency-NEPAD (AUDA-NEPAD). The 5-day training was conducted using the manual and covered introductory units and the assessment of pharmacokinetic studies. The overall aim of the training workshops is strengthening the evaluation process for marketing authorisation applications across the continent.
More than 90% of NRAs in Africa lack capacity to provide effective medical product oversight and only six regulators (Egypt, Ghana, Nigeria, South Africa, Tanzania, and Zimbabwe) have achieved WHO maturity level 3. To improve access to quality-assured, safe and efficacious medical products, it is important to have robust regulatory systems. Food and Drugs Authority,Ghana, as one of the NRAs operating at WHO maturity level 3, is therefore working with the United States Pharmacopoeia (USP) to empower regulators in Africa and share its expertise to improve access to quality medicines and strengthen the broader regulatory environment. This project is funded by the Bill & Melinda Gates Foundation for 2024 – 2025. The project goals and objectives are to:
More information about this project can be found here.
On 14 November 2024, the Food and Drugs Authority,Ghana, and the Korean Ministry of Food and Drug Safety (KMFDS) formalised their partnership by signing a Memorandum of Understanding (MoU) during the International Coalition of Medicines Regulatory Authorities (ICMRA) Summit in Brazil. This agreement marks a significant milestone in the collaboration that initially began in October 2023, following a preliminary meeting facilitated by the Right Foundation.
The MoU establishes a cooperative framework between the two regulatory bodies, grounded in the principles of equality, mutual benefit, and reciprocity. Its primary objective is to enhance information exchange and strengthen collaboration in the regulation of food and medical products, including pharmaceuticals, biopharmaceuticals (such as vaccines), and medical devices, with a particular focus on in vitro diagnostic devices.
The Ghana FDA delegation was led by Dr. Delese Mimi Darko , the Chief Executive Officer, and Dr. Akua Amartey, the Deputy CEO of the Technical Operations Division. The KMFDS delegation was headed by Sang Bong Kim, Director General of the Pharmaceutical Safety Bureau, alongside Hyun Song, Deputy Director of the Pharmaceutical Policy Bureau, and Hyeji Kim, Deputy Director of the Global Policy and Strategy Bureau.
The MoU outlines several key areas of cooperation, including the sharing of regulatory frameworks, administrative procedures, and best practices. Collaborative activities will include joint training programmes, capacity building initiatives for regulators and industry stakeholders, and efforts to improve food safety, medical product quality control, clinical trials, and post-market surveillance. The agreement is set to remain valid for five years, with an automatic renewal provision unless terminated by either party with six months' written notice. This collaboration represents a strategic effort to improve the regulatory landscape for food and medical products, contributing to the safety and well-being of both nations' populations.
On 1 November, Rwanda’s Ministry of Health Rwanda officially handed over the Alliance Building which will serve as the headquarters of the African Medicines Agency (AMA). In addition to the building, ten vehicles were donated to AMA. AMA is a specialised agency of the African Union, and its vision is to ensure that all Africans have access to quality-assured, safe, efficacious and affordable medical products, that meet internationally recognised standards, for priority diseases or conditions. The continental regulatory body was established through a treaty adopted by Heads of States and Government during their 32nd Ordinary Session of the Assembly on 11 February 2019 in Addis Ababa, Ethiopia. After the treaty had been ratified by the required minimum of 15 African countries, Rwanda was selected to host the agency and signed the host agreement on 10 June 2023. Work has been ongoing since then to operationalise the agency. The recruitment of the Director General of AMA is being finalised, and the chosen candidate will be announced in February 2025 at the AU Summit.
