Regulatory Spotlight - 09
December 16, 2024
Showcasing the latest developments, news and updates from African national medicines regulatory authorities.
Subscribe here.
The Medicines Control Authority Of Zimbabwe (MCAZ) has released its World Health Organization (WHO) Global Benchmarking Tool Assessment Report, following an assessment by the WHO Regulatory Systems Strengthening Team conducted on 14–15 May 2024. This step marks a major advance in transparency, reinforcing MCAZ’s commitment to core values such as customer focus, integrity, and accountability.
In making the report publicly accessible, MCAZ strengthens collaboration with industry partners, regulatory agencies, and stakeholders, aligning with its teamwork principle. Transparency is key to building trust and MCAZ aims to provide stakeholders with clear insight into its policies and operations, enabling informed decision-making. While other national medicines regulatory authorities have not yet published their assessment reports, MCAZ views this openness as vital for the growth of NRAs and encourages other regulators to follow suit. Stakeholders are invited to review MCAZ’s report and provide feedback to support further learning and development. The report can be accessed here.
The Egyptian Drug Authority- South African Health Products Regulatory Authority Work Sharing Initiative (WSI) for registration is part of the July 2023 Memorandum of Understanding (MoU) on mutual reliance for pharmaceuticals, biological products, and medical devices. As part of the MoU’s implementation, EDA and SAHPRA launched the WSI for registration, starting with a pilot phase focused on large molecule registration, with the aim of evaluating and refining the initiative before full implementation. The objectives of the EDA-SAHPRA WSI are to enhance regulatory efficiency to improve access to quality-assured, safe, and effective medical products; reduce unnecessary regulatory burden and duplication of efforts; and to promote the harmonisation of regulatory standards and requirements for the evaluation and authorisation of medical products. By participating in this joint assessment initiative, industry partners will have the opportunity to collaborate with leading African regulatory authorities to shape the future of regulatory policies and practices and contribute to the development of regulatory frameworks that support mutual reliance and access to medicines and vaccines. The deadline to submit applications is 28 February 2025. More information can be accessed via the links below:
The South African Health Products Regulatory Authority (SAHPRA) and the Therapeutic Goods Administration (TGA) have signed a Memorandum of Understanding (MoU) to strengthen collaboration between the regulators. SAHPRA and TGA have an existing relationship, and the MoU will build on it, improving capabilities in the assessment of medical products and the monitoring of their continued quality, safety and efficacy once they are granted marketing authorisation. In addition, the MoU enables data sharing to improve the regulatory functions that SAHPRA and TGA perform. The MoU also allows SAHPRA and TGA to expand the geographical reach of their pharmacovigilance programmes and augment their internal expertise.
The press release can be accessed here.
On 7 October 2024, SAHPRA, South Africa published Clinical Trials Committee meeting and submission dates for the year 2025. Applicants are therefore advised to submit clinical trial applications before the due date. SAHPRA will not accept applications submitted after the due date. If the proposed dates are changed, applicants will be informed in a timely manner.
The mandate of the National Drug Authority (NDA) of Uganda is to ensure the availability at all times of essential, efficacious and cost-effective healthcare products to the entire population of Uganda as a means of providing satisfactory healthcare and safeguarding the appropriate use of these products. Therefore, NDA implements a Quality Surveillance Plan aimed at monitoring the quality of medicines, surgical instruments and appliances, and other healthcare products regulated by NDA. This involves sampling of products earmarked for laboratory analysis and selection of products to be included on the plan using a risk-based approach. In line with the Quality Surveillance Plan, NDA has issued Circular No. 005/DIE/2024 to communicate products under mandatory sampling and analysis as a means of minimising any disruptions that may occur. The list of products can be accessed here.
The Tanzania Medicines and Medical Devices Authority (TMDA) has issued three new guidelines and six protocols for the control of medical devices and in-vitro diagnostic devices (IVDDs). These can be accessed here. Additionally, in line with its mandate to ensure transparency and provide access to reliable information, TMDA will begin publishing Public Assessment Reports (PARs) for registered medical devices and IVDDs that meet the established selection criteria. The aim of this initiative is to enhance public access to important evaluation reports for selected products and to ensure that stakeholders are well-informed about the quality, safety and performance of registered devices in Tanzania.
Only medical devices and IVDDs that meet the following criteria will be eligible for publication:
a) Treatment or diagnosis of infectious diseases of public interest such as HIV, Malaria, Hepatitis B & C, Syphilis and Tuberculosis.
b) Reproductive health products including those used for contraception and prevention of sexually transmitted infections, and
c) Those used during public health emergencies or at the point of care.
PARs will be published twice a year, at the end of the first and second halves of the financial year. Marketing Authorisation Holders will be given an opportunity to redact any proprietary or confidential information before the PAR is published. For further inquiries or clarifications, please contact TMDA medical devices registration section via email: medicaldevices@tmda.go.tz
The Government of Malawi, represented by the Pharmacy and Medicines Regulatory Authority (PMRA) Board Chairperson Mrs. Frider Chimimba, and the Government of India, represented by the Indian High Commissioner to Malawi Mr. S. Gopalakrishnan, signed a Memorandum of Understanding on pharmacopoeial cooperation. A key aspect of the agreement is to enhance cooperation in pharmacopoeia standards, particularly promoting understanding of the Indian Pharmacopoeia in regulatory frameworks, requirements and processes. This is important as most medicines that are on the Malawian market are manufactured in India. The MoU will also enable the exchange of information and documentation related to the development of analytical methods published in the Indian Pharmacopoeia.
The Pharmacy and Poisons Board (PPB) of Kenya conducted a 10-day intensive coached audit for its Good Manufacturing Practices (GMP) Inspectors, designed to enhance their practical auditing capabilities. The training was facilitated by World Health Organization appointed GMP consultants and involved visits to local manufacturing sites to address deficiencies identified during the previous WHO Global Benchmarking Tool audit. Participating PPB staff acquired advanced knowledge of pharmaceutical manufacturing standards and the latest WHO guidelines, thereby strengthening the regulatory oversight of the regulatory authority. In addition, PPB hosted a delegation from the Bill & Melinda Gates Foundation, BroadReach, and the University of Nairobi (UoN) to discuss the automation of PPB’s Key Performance Indicators and develop a performance dashboard aligned with WHO Global Benchmarking Tool standards. The dashboard is expected to enhance transparency and foster stronger collaboration with public and private sector players by allowing stakeholders to have access to real-time performance data. Furthermore, PPB convened the inaugural Partners Forum to strengthen collaboration among stakeholders and ensure a unified, strategic approach to regulatory systems strengthening. All these efforts by PPB are part of the regulatory body’s goal to attain WHO maturity level 3 by 2025.
The World Health Organization (WHO) has issued new guidance aimed at enhancing the design, implementation, and oversight of clinical trials across countries of varying income levels. This guidance seeks to enable stronger country-led research and development (R&D) ecosystems to advance health science, making new, safe, and effective health interventions more accessible and affordable to people worldwide in a timely manner.
For the first time, WHO provides recommendations for national health authorities, regulatory bodies, funders, and other stakeholders on how to effectively facilitate clinical trials that generate evidence on health interventions. The guidance addresses key challenges such as suboptimal trial design, lack of participant diversity, inadequate infrastructure, and bureaucratic inefficiencies, which can result in wasted time, resources, and ultimately, lives.
The African Union Development Agency – New Partnerships for Africa’s Development (AUDA-NEPAD) announced a significant milestone in advancing medical product regulation across Africa, with Wellcome awarding a grant of US $12,301,075 to support the strengthening and harmonisation of regulatory systems and the operationalisation of the African Medicines Agency.
Since its establishment in 2009, the African Medicines Regulatory Harmonisation (AMRH) initiative has played a crucial role in fostering a unified regulatory environment for Africa’s pharmaceutical sector. The initiative focuses on aligning regulations across Regional Economic Communities (RECs) to ensure access to quality assured, safe, and efficacious medical products and health technologies for African populations.
The Wellcome grant will further efforts to address regulatory capacity challenges that hinder access to essential medical products and technologies, in line with AMRH's objective of overcoming barriers such as limited human and institutional capacity, fragmented regulatory processes, and inconsistent technical standards.
Subscribe here.
