Regulatory Spotlight - 04
August 9, 2024
Showcasing the latest developments, news and updates from African national medicines regulatory authorities.
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The Submission Guidance for The Common Technical Document for Human Pharmaceutical Products Registration, which came into effect on 31 March 2024, is applied by the EDA (Egyptian Drug Authority) to local and imported pharmaceutical products. The guidance provides a standardised approach to the submission of regulatory information, enabling health authorities to easily review and evaluate data. It also outlines the format to be used by applicants when submitting a dossier to EDA, resulting in less time and effort to compile applications for registration of human pharmaceutical products. The guidance document can be accessed here.
The Nigerian regulatory body, National Agency for Food and Drug Administration and Control (NAFDAC), updated its ceiling list and will no longer accept new applications for marketing authorisation of imported pharmaceutical products on this list. The list now has 36 products. Renewal applications will be handled using the 5+5 policy pathway which requires applicants to submit a plan for migration to local production of the medical product. The current version of the ceiling list can be viewed here.
The 1st Continental Forum for Heads of Registration and Marketing Authorisation was held in Nairobi, Kenya on 11 April 2024. Among other topics, it discussed implementation processes for the continental pilot that will facilitate marketing authorisation of medical products in Africa, following Evaluation of Medicinal Products Technical Committee (EMP-TC) for human medicinal products’ recommendations. The gathering also served as a platform to elect the leadership of the Continental Medicine Registration Forum, that will support countries in implementing the adopted procedures. Kenya (Dr. Kariuki Gachoki) was elected as the Chair, Benin (Dr. Chantel Noufionso) as Vice Chair, and Senegal (Mbagnick Diof), Mozambique (Nazalia Macuwele) and Botswana (Bathusi Kgosietsile) serve as Rapporteurs.
The South African Health Products Regulatory Authority (SAHPRA) and the Botswana Medicines Regulatory Authority (BoMRA) signed a Memorandum of Understanding (MoU) aimed at strengthening medical products regulation to safeguard public health in the two countries. The two agencies will collaborate and share information on the assessment of medical product dossiers and improve the efficiency of their approval processes. In addition, the MoU enables the agencies to build robust post-marketing surveillance systems and conduct joint enforcement activities. Click here to access SAHPRA’s media release.
On 12 April 2024, the Director General of the Rwanda Food and Drugs Authority, Prof. Emile Bienvenu and the Chief Executive Officer of the South African Health Products Regulatory Authority(SAHPRA), Dr. Boitumelo Semete-Makokotlela, signed a Memorandum of Understanding to facilitate bilateral cooperation and mutual exchange of information and expertise on regulatory matters pertaining to medicines and vaccines.
SAHPRA and Rwanda FDA will cooperate in joint product reviews and inspections to enable efficient access to health products. The two regulators will also collaborate in mRNA vaccines regulatory oversight. This builds on a World Health Organization (WHO) initiative to establish an mRNA technology transfer hub in Africa, using a hub and spoke model, as a strategy to increase mRNA vaccine production capacity in under-served regions, and to promote regional health security. South Africa is the hub and Rwanda is one of six spokes. Click here to access SAHPRA’s media release.
The Food and Drugs Authority,Ghana hosted a delegation from the National Control Laboratory of the Democratic Republic of Congo (DCQ), for a five-day capacity-building study visit aimed at enhancing their knowledge in microbiology and medical device testing. The United States Pharmacopoeia (USP) Ghana oversees the initiative while the World Bank provides the funding.
The Bill & Melinda Gates Foundation hosted Heads of African national medicines regulatory authorities during the latest Steering Committee meeting of the African Union Development Agency – NEPAD's African Union Smart Safety Surveillance (AU-3S) initiative. AU-3S is the leading pharmacovigilance initiative in Africa; it is spearheading the establishment of a continental safety monitoring platform designed by African regulators to enable ownership and analysis of African data. Leaders from South Africa, Nigeria, Ghana, Ethiopia, Kenya, DRC, Egypt, Rwanda, Senegal, Tanzania, Uganda, and Mozambique attended the meeting.
Tunisia, in collaboration with the African Union Development Agency-NEPAD (AUDA-NEPAD) and the World Health Organization (WHO), hosted a preliminary meeting on the establishment of a North African Medicines Regulatory Harmonisation Initiative (NA-MRH). The NA-MRH will be part of the African Medicines Regulatory Harmonisation initiative established by AUDA-NEPAD. It was agreed that the interim Secretariat would be provided by Tunisia, and discussions on the implementation of the NA-MRH would continue until June 2024. Currently, regional harmonisation initiatives exist in five out of the eight officially recognised African Union blocs. These five are the Southern African Development Community (SADC), East African Community (EAC), Economic Community of West African States (ECOWAS), Economic Community of Central African States (ECCAS), and the Intergovernmental Authority on Development (IGAD). The regulatory harmonisation initiatives are at different maturity levels. Recognizing that NRAs cannot function in isolation, these North African countries are aiming to also set up their own harmonisation initiative to improve and streamline regulatory requirements by moving from a country-focused approach to a collaborative, regional approach. Medicines regulatory harmonisation is increasingly important given the globalised nature of pharmaceutical production and trade, and the growing complexity of medical products. Complex supply chains are extending NRAs’ responsibilities as they need to review copious amounts of information in marketing authorisation applications, as well as monitor various processes that take place outside their national borders, that may be beyond their capacities.
Global Health Protection Programme (GHPP) PharmaTrain2 fellows from the Medicines Control Authority Of Zimbabwe, the Food and Drugs Authority,Ghana, the Tanzania Medicine and Medical Devices Authority (TMDA) (TMDA) and the South African Health Products Regulatory Authority (SAHPRA) were guests at the annual clinical assessment workshop of the Federal Institute for Drugs and Medical Devices. This year’s workshop ran for two weeks and focused on pharmacokinetics. GHPP is an initiative of the German Federal Ministry of Health (Bundesministerium für Gesundheit) to strengthen global health protection. The aim of the PharmTrain2 project at the BfArM promotes regulatory capacity development at the African partner authorities, contributing to regulatory harmonisation in licensing of medical products in Africa.
According to Circular No. 00824/AIRP dated 19th April 2024, Novartis, in collaboration with the NRA of Côte d’Ivoire, is withdrawing VOLTARENE (Diclofenac) 12.5 mg suppositories box of 10 from Côte d’Ivoire’s market for commercial reasons. The registration imports certificate E-2019-1088 is therefore repealed.
Zanzibar joins the World Health Organization (WHO) Programme for International Drug Monitoring (PIDM) as the 157th member. Created in 1968, the WHO PIDM ensures that evidence about harm to patients is collected from as many sources as possible. This enables individual countries to be alerted to patterns of harm emerging across the world which might not be evident from their local data alone. Members of the programme work nationally and collaborate internationally to monitor and identify adverse effects of medicines and vaccines, to reduce the risks to patients, and to establish worldwide pharmacovigilance standards and systems. The list of full and associate members can be viewed here.
The Board of the African Medicines Agency (AMA) was appointed on 22 April 2024, bringing the continent closer to having a fully operational continental regulator. Yossounon CHABI, the Director General of the Beninese Agency for Medicines and Other Health Products, was appointed as the Chairperson of the AMA Governing Board and will serve for a three-year term. After the Africa Centers for Disease Control and Prevention (Africa CDC), the AMA is the second health agency that will enhance the capacity of states and regional economic communities (RECs) to regulate medical products to improve access to high-quality, safe, and efficacious medical products on the continent. The AMA will also promote the adoption and harmonisation of medical products regulatory policies and standards, as well as provide scientific guidelines and coordinate existing regulatory harmonisation efforts in the AU-recognised RECs and regional health organisations.
Several African regulators issued recalls for Benylin paediatric 100mls cough syrup with batch numbers 329304 and 329303 manufactured by KenvuePro (formerly Johnson and Johnson) in South Africa. The product is used for the relief of cough and its congestive symptoms and for the treatment of hay fever and other allergic conditions affecting the upper respiratory tract. The batches were recalled due to reported high levels of diethylene glycol (DEG), a contaminant which is toxic to humans when consumed and can result in death. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headaches, altered mental state, and acute kidney injury which may lead to death. The product was distributed to South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria. All these countries have recalled the affected batches, so have Botswana, Zimbabwe, and Ghana. MCAZ, Zimbabwe published Circular 10 of 2024 with pro-active measures for pharmaceutical manufacturers to ensure that all liquid formulations registered by the Authority are not contaminated with DEG and ethylene glycol. This is a useful resource for manufacturers to consult.
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