Regulatory Spotlight - 07
December 16, 2024
Showcasing the latest developments, news and updates from African national medicines regulatory authorities.
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The Regulatory Capacity Development Technical Committee (RCD-TC) of the African Medicines Regulatory Harmonisation (AMRH) initiative hosted an interim Executive Committee meeting to discuss the establishment of the College for African Regulatory Science Professionals (CARSP). The mandate of the RCD-TC is to provide technical advice to the AMRH Steering Committee on human resources development needs to strengthen medicines regulatory capacities and systems in Africa.
CARSP is being established in response to human resource challenges being faced on the continent, particularly in national medicines regulatory authorities (NRAs). It will build on the efforts of the AMRH initiative which has played an instrumental role in strengthening and harmonising the fragmented regulatory systems in Africa including through the designation of Regional Centres of Regulatory Excellence (RCOREs). Despite RCOREs offering about 70 short courses, postgraduate diplomas, and Masters programmes to more than 1500 personnel from NRAs, academic institutions and pharmaceutical industry in Africa between 2014 and 2022, capacity constraints still exist. Therefore, CARSP is being established to provide a systematic approach to address the human resource constraints on the continent by ensuring the availability of a critical mass of qualified regulatory science professionals. The proposed objectives of the College are to establish and maintain a competency framework for regulators and industry in Africa, define training pathways using existing resources and opportunities, assess and recognise professionals, advance education and training standards of regulatory professionals, advance practice and research in regulatory sciences, and assess, recognise or designate new training programmes, institutions and schools.
From 29 July 2024 to 2 August 2024, pharmacists at the Ivorian Pharmaceutical Regulatory Authority (AIRP) participated in an intensive training aimed at strengthening the skills of pharmacists in the control and inspection of pharmaceutical establishments, in accordance with Law No. 2017-541 of 3 August 2017 on the regulation of the pharmaceutical sector. This AIRP initiative is part of a capacity building approach to ensure effective regulation of the pharmaceutical sector and protect public health in Côte d'Ivoire. The training was conducted in collaboration with the École des Hautes Études en Santé Publique (EHESP) from France.
The Ghana FDA’s CEO, Dr. Delese Darko, renewed their commitment to collaborate with the Malta Medicines Authority by signing a Memorandum of Understanding (MoU) with her counterpart Prof. Anthony Serracino-Inglott. The MoU builds on a broader agreement signed in 2019 by the Ministers of Foreign Affairs from Ghana and Malta, aimed at fostering closer ties between the two regulatory bodies. The renewed partnership focuses on advancing science and technology, enhancing capacity development in regulatory sciences, and sharing marketing authorisation and pharmacovigilance information.
Ghana FDA was re-benchmarked by a 16-member World Health Organization (WHO) delegation from 22 – 26 July 2024. Benchmarking is 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). Ghana FDA is one of six African regulators who have maturity level 3 status, and the re-benchmarking exercise was to assess the regulator’s maintenance of maturity level 3 requirements.
From 18 – 19 July 2024, World Health Organization (WHO) assessors were hosted by the Botswana Medicines Regulatory Authority (BoMRA) and the WHO country office to undertake a benchmarking pre-visit. The visit was the first step in the formal benchmarking process and gave the WHO assessors a preliminary overview of the status of the Botswana regulatory system. The assessors also interacted with BoMRA’s critical stakeholders, including the BoMRA Board and leadership of the Ministry of Health. BoMRA has been conducting self-benchmarking annually since 2020 and is working towards attaining maturity level 3.
BoMRA, Botswana is calling on applicants to register their medical devices including in vitro diagnostics. Mandatory registration is applicable to WHO Prequalified IVD test kits or same IVD test kits approved by Stringent Regulatory Authorities (i.e. NRAs of the United States of America, Canada, Australia, Japan, European Union, and the United Kingdom), all instruments compatible with WHO PQ/SRA approved IVD test kits, all locally manufactured medical devices including IVDs, all SRA approved contraceptive devices (and their lubricants), pregnancy test kits and implants for central nervous system, SADC approved contraceptives, and the following Maternal Newborn and Child Health (MNCH) devices that are SRA approved: neonatal ventilators, CPAP ventilators, oxygen blenders, oxygen concentrators, pulse oximeters, humidifiers, flow splitters, suction pumps, bilirubinometer, phototherapy lights, radiant warmers, infant incubators, mobile diagnostic ultrasound scanners, fetal dopplers, non-pneumatic anti-shock garments, vacuum extractors, blood pressure machines and hemoglobinometers.
All medical devices called for registration will be removed from the medical devices listing register effective from 1 April 2025. All other remaining listed medical devices will be subjected to an annual retention fee to retain them in the listing register; retention fees should be paid between 1 January – 31 March 2025. All medical devices including IVDs not retained will be removed from the listing register from 1 April 2025.
Applications will be received through BoMRA’s online service portal: https://brims.bomra.co.bw/
For any enquiries, contact: medicaldevices.services@bomra.co.bw
On 25 July 2024, the Rwanda Food and Drugs Authority (Rwanda FDA), the University of Rwanda (UR), the Rwanda Forensic Institute (RFI), the Rwanda Biomedical Centre (RBC), and the African Biomanufacturing Institute (ABI) signed a Memorandum of Understanding (MoU) with the International Centre for Genetic Engineering and Biotechnology (ICGEB). ICGEB is an international, intergovernmental organisation conceived as a centre of excellence for research, training and technology transfer to industry in the field of biotechnology to promote sustainable global development. Rwanda FDA’s partnership with ICGEB will enable the Authority to access ICGEB’s state-of-the-art laboratory facilities and receive advanced Good Manufacturing Practice (GMP) training for new technologies relating to biological manufacturing.
In a significant effort to protect public health, the Pharmacy and Poisons Board (PPB) of Kenya and the National Drug Authority (NDA) of Uganda, in collaboration with international partners, successfully concluded "Operation African Star". This four-day initiative involved thorough inspections of health product shipments and reciprocal training to enhance local authorities' capabilities in detecting and intercepting illicit medical products. Supported by counterpart agencies from the United States, United Kingdom, European Union, and international bodies such as the Organization for Economic Co-operation and Development and the United Nations International Narcotics Control Board, the operation uncovered violations including improper storage, prescription drugs without valid prescriptions, and dietary supplements containing undeclared active ingredients.
From 15 – 26 July 2024, the Pharmacy and Poisons Board (PPB) of Kenya hosted a knowledge sharing visit from the Southern Region Pharmacovigilance Centre of Malawi, Kamuzu University of Health Science. PPB is the Regional Centre of Regulatory Excellence for Pharmacovigilance in Africa and is committed to fostering collaboration among member states to improve patient safety through effective drug monitoring. Experts from Kenya and Malawi used the visit to exchange best practices and experiences in pharmacovigilance. They also intend to enhance drug safety surveillance systems, leading to quicker identification and response to adverse drug reactions.
The Pharmacy and Poisons Board (PPB) of Kenya has acquired Pillscan, an advanced Near Infrared (NIR) technology, to strengthen its ability to ensure medical product quality and safety. The tool, which was provided by the Mission for Essential Medicines and Supplies, has the capability to detect substandard and falsified medical products and will be used for on-site screening of medical products at PPB regional offices and key entry points. It will also reinforce its surveillance of the pharmaceutical market in Kenya.
On 30 July 2024, the South African Health Products Regulatory Authority (SAHPRA) published a communication to stakeholders which concluded that the current scientific data for orally administered phenylephrine as a nasal decongestant was inadequate and did not support its efficacy at recommended dosages as a nasal decongestant. There are no safety concerns associated with use of orally administered phenylephrine at the recommended dose. SAHPRA’s Advisory Clinical Committee (ACC) therefore recommends that: 1. All phenylephrine containing orally administered medicines that are currently not registered be called up for registration within 90 days of receiving this recommendation. 2. All holders of the certificates of registration for orally administered phenylephrine containing medicines provide comment on the ongoing benefit/risk of their product with supporting data within 90 days of receiving this recommendation.
The South African Health Products Regulatory Authority (SAHPRA) Advisory Clinical Committee (ACC) reviewed data submitted by Holders of Certificates of Registration (HCRs) to support the continued use of codeine in children under 12 years and concluded that there is evidence indicating that codeine-containing medicines are associated with respiratory complications when used in children under 12. Several publications, including Periodic Safety Update Reports (PSURs) and Periodic Benefit-risk Evaluation Reports (PBRERs), report an unacceptable risk, including fatal outcomes when codeine-containing medicines have been administered to children.
SAHPRA is therefore implementing safety restrictions in the paediatric population and now requires HCRs of codeine-containing medicines to include a contraindication for use in children under 12. Similar considerations apply to breastfeeding women as there are similar outcomes in infants of breastfeeding mothers who have taken codeine-containing products. Additionally, adverse events have been reported in neonates born to mothers who have recently consumed codeine-containing products. Bearing this in mind, SAHPRA recommends that HCRs of codeine-containing products amend their PI and PILs as follows:
Contraindications:
1. Children under the age of 12 years.
2. Women who are breastfeeding their infants and women in the third trimester of pregnancy.
3. Codeine should not be used at all in children (aged below 18 years) who undergo surgery for the removal of the tonsils or adenoids to treat obstructive sleep apnoea, as these patients are more susceptible to respiratory problems.
Special warnings and precautions for use:
1. Include a warning that children with conditions associated with respiratory problems should not use codeine.
2. The PIL to be aligned accordingly
The SAHPRA communication to stakeholders is accessible here.
The South African Health Products Regulatory Authority (SAHPRA) will be implementing a process to renew the validity of human and veterinary medicine registrations. It has published a Medicines Registration Renewals Implementation Framework that covers health product registration renewals for all medicines, except for complementary medicines, medical devices and in-vitro diagnostics (as these products are not currently being registered by SAHPRA). This process is being implemented to comply with legal provisions, WHO Global Benchmarking Tool requirements, and WHO Review Practice guidelines. Renewal applications must be submitted to SAHPRA six months prior to the expiry of the health product registration and the required fees paid. The renewal fees will be published for public comment and submitted for gazetting, upon which renewal fees will be introduced. Until such a time, renewal fees will not be payable in advance and invoices will only be sent to applicants at the end of the review process upon renewal outcome decision. Failure to submit a complete and compliant renewal application may result in registration expiry and the product registration no longer being valid. If the product registration has expired, the applicant must submit a new product registration application.
On 15 July 2024, the Medicines Control Authority of Zimbabwe (MCAZ) announced plans to introduce a comprehensive regulatory framework for cosmetic products sold within the country. The regulations, known as Medicines and Allied Substances Control (Cosmetics) Regulations, aim to address growing concerns over the proliferation of substandard, falsified, and potentially harmful cosmetic products in Zimbabwe. MCAZ has identified several issues requiring stricter oversight, including the use of harmful ingredients, poor product quality, and lack of traceability. MCAZ, under the proposed regulatory framework, will establish guidelines for defining, registering, labelling and testing cosmetic products. Manufacturers, importers and distributors will also be required to comply with stringent safety and quality standards, submit detailed product information for evaluation, and adhere to prescribed labelling and marketing practices. MCAZ is engaging stakeholders to finalise the draft regulations aimed at protecting Zimbabwean consumers' health. Regulating the cosmetics sector seeks to restore market confidence, promote innovation, and enable informed consumer choices. The regulations are expected to be implemented soon, following legislative processes. The MCAZ is urging all stakeholders to participate and advises public caution in using certain cosmetics.
The media release can be accessed here.
The European Medicines Agency (EMA) has awarded a grant to the African Medicines Regulatory Harmonisation (AMRH) initiative of the African Union Development Agency (AUDA-NEPAD) to support a pilot to test procedures for the joint continental evaluation of medicines in Africa. The launch of the continental pilot aims to validate procedures and processes ahead of the establishment of the African Medicines Agency (AMA). The pilot is being co-funded with the Bill & Melinda Gates Foundation and will run for a year. During this period, the AMRH Evaluation of Medicinal Products Technical Committee (EMP-TC) will evaluate the quality, safety and efficacy of priority medicinal products with the support of the continental Good Manufacturing Practices Technical Committee (GMP-TC). The lessons learned will be used to develop continental processes and procedures, facilitate national authorisations of recommended medicines and strengthen information sharing and reliance.
The full article can be read on the EMA’s website.
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