Regulatory Spotlight - 02
August 9, 2024
Showcasing the latest developments, news and updates from African national medicines regulatory authorities.
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The African Union Development Agency – New Partnerships for Africa’s Development (African Union Development Agency-NEPAD) hosted the 3rd Medicines Policy and Regulatory Reforms (MPRR) Technical Committee meeting from 27 – 29 February 2024 in Midrand, South Africa. The meeting was part of AUDA-NEPAD's ongoing support to African countries towards national domestication of the AU Model Law on Medical Products Regulation. The model law serves as a comprehensive legislative template that is used to achieve regulatory harmonisation in line with international standards and best practices. The meeting also served as a platform for committee members and partners to review and provide input to proposed amendments to the model law, following a review and recommendations by Market Access Africa. The proposed amendments will be presented to the AU Specialized Technical Committee (AU-STC) on Justice and Legal Affairs and African Ministers of Health at meetings scheduled for later this year.
The Medicines Control Authority Of Zimbabwe (MCAZ) has extended the waiver of levy fees for applications for re-registrations to 30 April 2024. The Authority has stated in Circular 4 of 2024 that some applications for re-registration do not comply with its re-registration guidelines and such applications will be rejected after the assessment process. However, the affected products will continue to have marketing authorisation rights until 31 December 2027. Applicants, principals and manufacturers are therefore encouraged to use the additional time to submit complete re-registration applications to avoid disappointment. MCAZ will levy fees from 1 May 2024 for new applications for re-registration as well as for incomplete re-registration applications that have already been received.
The South African Health Products Regulatory Authority (SAHPRA) updated its Guidelines for medicine recall/withdrawal and rapid alert on 15 February 2024. The guideline serves as a recommendation to applicants regarding the recalls and withdrawal of medicines, and SAHPRA’s current thinking on the quality, safety and efficacy of medicines. SAHPRA has stated that it reserves the right to request any additional information to establish the quality, safety and efficacy of a medicine and may make amendments in keeping with the knowledge which is current at the time of consideration of data that has been submitted regarding any recalls. The amendments to the guidelines include:
The Botswana Medicines Regulatory Authority (BOMRA) published a call on 20 February 2024 for applicants to register their medical devices with the Authority as a step towards registering these products in the Botswana market. There are two registration options: voluntary registration and mandatory registration.
Voluntary Registration
Mandatory Registration
All medical devices called for registration will be removed from the medical devices listing register effective from 1 January 2025. All other listed medical devices including IVDs will be subjected to retention fees to be paid between 1 January to 31 March 2025.
Rwanda Food and Drugs Authority hosted the World Health Organization (WHO) Regulatory System Strengthening team for three days to finalize benchmarking of the Authority which started on 12 December 2022. The benchmarking exercise was based on the global benchmarking tool (GBT), which is the primary tool with which WHO assesses regulatory systems for regulating medical products, ranking them from maturity level 1 (existence of some regulatory elements) to maturity level 4 (operating at advanced level of performance and continuous improvement). The tool and benchmarking methodology enable WHO and regulatory authorities to identify areas of strength as well as areas for improvement, and then to facilitate the formulation of institutional development plans (IDP) to address identified gaps, to aid in the prioritization of investments for implementing the IDP, and to help monitor progress. Rwanda is aiming for maturity level 3 status. To date, the five African countries with maturity level 3 status are Tanzania, Ghana, Nigeria, Egypt and South Africa. No NRA in Africa operates at maturity level 4.
A team from the Paul-Ehrlich-Institut’s ‘Blood Train’ visited Ghana FDA for a three-day working visit as part of a collaboration between the two institutions to strengthen blood regulation in Ghana. The Food and Drugs Authority,Ghana is committed to elevating the standards for the regulation of blood and blood products to improve patient safety in Ghana.
The Food and Drugs Authority,Ghana has published a draft guideline for public consultation on identification and data capture for pharmaceutical traceability. This is in response to requirements outlined in the World Health Organization (WHO) Global Benchmarking Market Surveillance and Control function indicator MC.01.05. The indicator calls for the implementation of legal provisions and regulations for placing unique identification numbers on outer packaging of products, as a way of countering substandard and falsified medical products. Substandard and falsified medical products are a major concern in Africa and this guideline is intended to enhance access to traceable quality-assured, safe and efficacious medical products for Ghanaians, in line with the country’s national pharmaceutical traceability strategy. The guideline can be accessed here. Comments should be sent to this email enforcement@fda.gov.gh referencing the document page and line number.
The Egyptian Drug Authority (EDA) published the Egyptian Drug Formulary (Cardiovascular Chapter) Manual, which will support healthcare professionals to make the right clinical decisions by providing them with accessible and reliable information about the available medications in the Egyptian drug database. The document contains a list of medicines that are registered in the Egyptian drug database, and which are included in the essential medicines list or widely used on the Egyptian pharmaceutical market. The database is designed according to drug monographs, classified pharmacologically and arranged alphabetically.
African Union Development Agency-NEPAD (AUDA-NEPAD) has published a Compendium of Continental Guidelines for the Pilot of Listing of Human Medicinal Products. This resource will assist applicants to navigate marketing authorisation and listing procedures for pharmaceuticals and biological products in Africa. The compendium will also enable streamlined product listing procedures and facilitate a harmonised medicinal regulatory system. The compendium can be accessed here.
On 14 February 2024, Cote d’Ivoire adopted a decree ratifying the Treaty for the Establishment of the African Medicines Agency. The African Medicines Agency (AMA) Treaty was adopted by African Heads of States and Government during their 32nd Ordinary Session of the Assembly on 11 February 2019 in Addis Ababa, Ethiopia. Among other aspirations, the AMA aims to enhance the capacity of national medicines regulatory authorities (NRAs) and regional blocs in Africa to regulate medical products to improve access to quality, safe and efficacious medical products. AMA builds on the African Medicines Regulatory Harmonization (AMRH) initiative, which was established in 2009, and is currently led by AUDA-NEPAD. Côte d'Ivoire's accession to the AMA Treaty brings to 27 the number of African countries that have ratified the Treaty.
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