Regulatory Spotlight - 06
August 9, 2024
Showcasing the latest developments, news and updates from African national medicines regulatory authorities.
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Following a comprehensive benchmarking exercise and the successful implementation of recommendations made by the World Health Organization (WHO), the Medicines Control Authority Of Zimbabwe (MCAZ) has attained Maturity Level 3 (ML 3) for the regulation of medicines and vaccines (non-producing). The benchmarking exercise was based on the global benchmarking tool (GBT), which is the primary standard by which the WHO assesses country systems for regulating medical products, ranking them from maturity level 1 (existence of some regulatory elements) to maturity level 4 (operating at an advanced level of performance and continuous improvement). The tool and benchmarking methodology are used by WHO and NRAs 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, prioritise investments for implementing the IDP, and to help monitor progress.
Zimbabwe is the sixth African country to obtain ML 3 status. The other five countries are Tanzania (2018), Ghana (2020), Nigeria, South Africa and Egypt (2022).
The media release can be accessed here.
The Medicines Control Authority Of Zimbabwe (MCAZ) signed a Memorandum of Understanding (MoU) with the Republican Unitary Enterprise Center for Examinations and Tests in Health Service (RUE-CETH) Belarus. The MoU establishes a framework for cooperation and collaboration between the two organisations aimed at enhancing regulatory standards, ensuring the quality, safety and efficacy of medicines, and fostering innovation in the pharmaceutical sector. It is the intention of the MCAZ and RUE-CETH to leverage their relative expertise, promote public health, and improve access to quality assured medical products. The media release can be read here.
The Medicines Control Authority Of Zimbabwe (MCAZ), has published the Pharmacovigilance Guidance for Pharmaceutical Industry. The guidelines provide information to all marketing authorisation holders (MAHs), principals, applicants, manufacturers and local representatives of registered products to support the continuous safety monitoring of products that have been granted marketing authorisation or are registered in Zimbabwe. The guidelines apply to all registered medicinal products in Zimbabwe.
MAHs are required to establish a vigilance system for their medicinal products and periodically report vigilance data to MCAZ. Given the limitations of clinical trials in terms of patient numbers, exclusion of at-risk patients, lack of long-term treatment experience and limitations related to administration of concomitant therapies, it is difficult to detect or confirm rare adverse reactions. Therefore, continuous safety monitoring is critical as the risk-benefit balance of a product may change over time. The guidelines outline the requirements for post-approval safety monitoring of registered medicinal products, including Periodic Safety Update Reports (PSUR), Periodic Benefit Risk Evaluation Reports (PBRER), Risk Management Plans (RMP), Post-Authorisation Safety Studies (PASS), Post-Authorisation Efficacy Studies (PAES), safety variations, safety communication, distribution category changes, and Good Pharmacovigilance Practices (GVP) requirements, including Qualified Persons for Pharmacovigilance (QPPV) and the structure and content of the Pharmacovigilance System Master File (PSMF).
From 9 – 13 June 2024, the Egyptian Drug Authority (EDA) hosted regulators from Senegal and Botswana, as part of the first round of the twinning programme for regulatory laboratories in Africa, focusing on the analysis and release of vaccines. The objectives of the programme include sharing best practices and skills, as well as equipping laboratories to independently enhance and maintain their quality control services. The meeting addressed mechanisms for strengthening the laboratory capacities of regulatory authorities across the continent to ensure the quality of vaccines and other biopreparations in Africa. Representatives from EDA made presentations on the operation of regulatory laboratories and the release of vaccine batches. This first round of the twinning programme for regulatory laboratories, initiated by the African Union Development Agency (AUDA-NEPAD), is part of the activities of the African Medicines Quality Forum (AMQF) Technical Committee of the African Medicines Regulatory Harmonisation (AMRH) initiative.
As part of the activities at the Africa Health ExCon Conference, the Unified Procurement Authority signed a Memorandum of Understanding (MoU) with the Egyptian Drug Authority (EDA)to cooperate in implementation of the drug tracking system. This system is used to track medicines from production, all the way to the final consumer, ensuring their safety and quality by monitoring the supply chain and preventing the entry of substandard and falsified medicines into the market. The MoU was signed by the respective Chairmans of the two authorities - Dr. Ali Al-Ghamrawy (EDA), and Major General Dr. Bahaa Zeidan (UPA). This initiative is in line with the Egyptian Drug Authority's commitment to advance the implementation and dissemination of the drug tracking system, and to cooperate with all relevant authorities in this effort.
During the third edition of the Africa Health ExCon, the Egyptian Drug Authority (EDA)signed a Memorandum of Understanding with the Zambia Medicines Regulatory Authority (ZAMRA), a milestone in its ongoing efforts to enhance cooperation with African countries. The MoU aims to strengthen regulatory frameworks through the exchange of knowledge and experiences, enhancing medicine control mechanisms and promoting continuous learning. It also represents a shared commitment to promoting public health and meeting the Zambian market's needs for Egyptian medical products. Additionally, the MoU outlines that ZAMRA will rely on the EDA for the registration and marketing authorisation of medical and biological products, based on World Health Organization (WHO) guidelines. Furthermore, the MoU includes initiatives for capacity building through virtual or in-person training courses for ZAMRA.
The Tanzania Medicines and Medical Devices Authority (TMDA) recently conducted a comprehensive assessment of all products containing ampicillin as a single moiety. This review found that microorganisms, including Klebsiella pneumoniae, Escherichia coli, other Klebsiella spp, and Proteus spp, have developed resistance to ampicillin monotherapies. Some studies reviewed during this assessment indicated that resistance has reached up to 100% in certain East African Partner States. In view of this, TMDA has decided to cancel the marketing authorisation of medicinal products containing ampicillin as monotherapy across all dosage forms. All marketing authorisation holders of the affected products are advised to reformulate their products into different combinations to ensure effectiveness against bacterial infections. Additionally, TMDA informs its stakeholders that new applications for registration or renewal applications for ampicillin monotherapy products will not be accepted. The public notice can be accessed here.
As part of efforts to create a conducive business environment in Tanzania, the Tanzania Medicines and Medical Devices Authority (TMDA) has reviewed the current Fees and Charges Regulations to accommodate various stakeholders' recommendations. In view of this, stakeholders are kindly requested to submit their comments on the revised fee structure by 10 July 2024. Comments should be sent electronically to TMDA via email at gati.museti@tmda.go.tz
The Draft Regulations can be accessed here.
In a significant step toward achieving vaccine self-sufficiency and enhancing its global public health impact, the Food and Drugs Authority,Ghana (FDA) has partnered with the European Union-German Corporation for International Cooperation (EU-GIZ). This collaboration aims to advance vaccine regulation in Ghana through several initiatives.
As part of this commitment, FDA staff have successfully completed two essential training programmes: a hands-on Assessor training program and a customised hands-on Vaccine Good Manufacturing Practice (GMP) training programme. A third training programme is scheduled for September 2024. These training programmes are pivotal in the strengthening of FDA’s human resource capacity for vaccine regulation, enabling effective oversight of vaccine quality and safety.
The EU-GIZ sponsored project also includes a significant infrastructure upgrade for the FDA’s pharmaceutical microbiology laboratory. This upgrade involves constructing an ISO Class 7 cleanroom with a Class 8 background and an isolator, adhering to biosafety level 2 standards. This state-of-the-art facility will provide a controlled environment for vaccine testing, ensuring strict safety protocols are met.
The cleanroom construction is progressing well, with completion expected by November 2024. Once operational, it will significantly enhance the FDA’s capabilities in medicines and vaccine testing. This collaboration between the FDA and EU-GIZ exemplifies the strength of international partnerships in advancing public health objectives.
A United States Food & Drug Administration (USFDA) delegation, led by Associate Commissioner for Global Policy and Strategy Mark Abdoo , visited Kenya and Rwanda, to engage with regulators, multilateral organisations, industry, academia, and civil society. The June 2024 visit began with a meeting at Kenya’s Ministry of Health (MOH) to discuss potential FDA support with MOH’s Acting Director General Dr. Patrick Amoth. The delegation also visited the Pharmacy and Poisons Board (PPB), where Associate Commissioner Abdoo signed a Statement of Cooperation (SOC) with PPB’s Director of Health Products and Technologies, Dr. Ahmed Mohamed, to enhance cooperative engagement in regulatory and scientific matters and public health protection. The SOC follows a confidentiality commitment on medical devices signed on 15 March 2024 in Washington, D.C., establishing a legal framework for sharing nonpublic information between the two regulatory authorities. Additionally, the FDA delegation visited the WHO’s regional office in Nairobi, meeting with World Health Organization's representative to Kenya, Dr. Abdourahmane Diallo, to discuss regulatory work in Africa and identify collaboration opportunities. On 21 June 2024, the delegation participated in a roundtable with Kenyan pharmaceutical leaders to explore improving pharmaceutical manufacturing, noting Kenya’s emergence as a pharmaceutical hub in East Africa. The delegation also visited Kigali, Rwanda.
The Botswana Medicines Regulatory Authority (BoMRA) has launched the BoMRA Regulatory Information Management System (BRIMS), a web-based platform designed to automate all regulatory processes. BRIMS aims to enhance efficiency and streamline services for stakeholders by enabling online transactions such as applications for screening, registration, variations, renewal of registration, exemption from registration, and product retentions across different registers. Stakeholders can also make payments for these services using debit or credit cards directly through BRIMS. Effective from 31 July 2024, manual applications for these services will no longer be accepted, although BoMRA will continue to assist applicants in uploading their applications onto the system until that date. The public notice, which includes account opening details, can be accessed here.
Members of the Evaluation of Medicinal Products Technical Committee (EMP TC), established by the African Medicines Regulatory Harmonisation (AMRH) initiative, exchanged experiences with EMA colleagues and observed the monthly meeting of the human medicines committee (CHMP). The regulatory experts from across Africa were hosted in Amsterdam by the European Medicines Agency (EMA). This visit supports the establishment of the African Medicines Agency (AMA) by sharing EMA's regulatory knowledge and insights. The expertise of these technical committees strengthens regulatory systems across African countries, playing a crucial role in the future AMA. Over the past three decades, EMA has developed a successful model for continental medicines regulation based on cooperation and dialogue, and the European regulator is helping African colleagues ensure patients have access to safe, effective, and high-quality medicines.
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