Regulatory Spotlight - 05
August 9, 2024
Showcasing the latest developments, news and updates from African national medicines regulatory authorities.
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The prevalence of substandard and falsified (SF) medicines is high in developing countries, and Africa is reported to be the destination for about 42% of all SF medical products globally. To address the SF problem within its borders, the Zanzibar Food and Drug Agency (ZFDA), in collaboration with other actors in Zanzibar, has adopted a security label with a serial number, barcode and two-factor authentication system protection. The aim is for local importers and distributors of medical products to use the label, enabling ZFDA and the public to trace and authenticate products at any point along the supply chain, ultimately curbing the circulation of substandard and falsified products. The news article can be read here.
The Tanzania Medicines and Medical Devices Authority (TMDA), in partnership with USAID Medicines, Technologies, and Pharmaceutical Services (MTaPS) programme, organised a stakeholders’ meeting on 10 May 2024. The meeting focused on the Draft Guidelines for Good Storage and Distribution Practices (GSDP), which aim to translate and simplify the implementation of the legal requirements outlined in the GSDP Regulations, 2021. The draft guidelines cover general GSDP principles, organisation and personnel, Quality Management Systems (QMS), premises, warehousing and storage facilities, vehicles and equipment, donations, and self-inspection. They also include a checklist and forms to be used by inspectors during audits. Following the meeting, TMDA will review the feedback from participants and incorporate it as necessary, prior to publishing the definitive version of the guidelines.
Dr. Ayman Al-Khatib (Vice President of the Egyptian Drug Authority), received Dr. Wejdan Al-Fil, (Head of the Office of the Sudanese Council for Drugs and Poisons) and other delegates in Egypt to discuss operational matters of the office which their Sudanese counterparts intend to open in Egypt. This move follows a decision by Sudan to import Egyptian pharmaceuticals that have received marketing authorisation from the EDA and are on the Sudanese list of priority medicines. EDA is committed to providing technical capacity development programmes, with the aim of supporting and developing human resources working in the pharmaceutical sector at the local and regional levels. The bilateral collaboration between Egypt and Sudan began last year.
From 29 April to 3 May 2024, the World Health Organization (WHO) conducted the formal benchmarking of Senegal’s national medicines regulatory authority (NRA), the Agence sénégalaise de Réglementation pharmaceutique (ARP). This is the first Francophone African NRA to be benchmarked. The benchmarking exercise was based on the global benchmarking tool (GBT), which is the primary tool with which the 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 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, prioritization of investments for implementing the IDP, and to help monitor progress. Senegal is aiming for maturity level 3 – the highest status attained by any of the African NRAs. If it is successful, it will join the five African regulators (Tanzania, Ghana, Nigeria, Egypt and South Africa) with this status.
A Southern African Development Community (SADC) Med Database Application was launched on 14 May 2024 in Dar es Salaam, Tanzania. This follows the ministers of health endorsement of the technical review on the operationalisation of the SADC Pooled Procurement Services (SPPS) at their meeting held in Luanda, Angola on 29 November 2023. The database, developed through the European Union-funded Support to Industrialisation and Productive Sectors (SIPS) programme, aims to increase equitable access to essential quality medicines and health commodities by sharing information of pharmaceutical procurement data in participating countries.
The Pharmacy and Poisons Board of Kenya (PPB) hosted a delegation from The World Bank on 17 May 2024. The focus of the meeting was to understand the mandate of PPB and its progress towards attaining WHO maturity level 3 status. In addition, the meeting explored potential collaborations to strengthen regulatory frameworks and address shared pharmaceutical sector challenges. Representatives from São Tomé and Príncipe, Burundi, the Democratic Republic of Congo, the Intergovernmental Authority on Development (IGAD), and ECSA also attended the meeting.
The South African Health Products Regulatory Authority (SAHPRA) has attained ISO 9001:2015 certification following a South African Bureau of Standards (SABS) audit. The ISO 9001 standard is an international standard for quality management systems developed by the International Organisation for Standardisation (ISO). The certification means that South African Health Products Regulatory Authority has a robust and effective QMS and can achieve quality standards that ensure that health products on the South African market meet quality, safety and efficacy standards. SAHPRA is also now aligned with the Regional Strategy for the Regulation of Medicinal Products which aims to see all member states having functional national medicines regulatory authorities with systems for quality management by 2025. Access the full press release here.
SAHPRA is conducting a feasibility study for medical device registration to validate the proposed process for registration of medical devices. The feasibility study applies only to medical devices intended for human use and aims to provide an approach to register medical devices which are currently either legally imported into South Africa or manufactured in South Africa. SAHPRA intends to include various IVDs and non-IVDs used to diagnose and monitor HIV and TB into the study, and will ideally include both medical devices manufactured in South Africa and imported class C and D medical devices. The closing date for submissions is 28 June 2024. The requirements, procedures and relevant documents can be accessed here.
SAHPRA is currently reviewing active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs) of specific medicines containing APIs which have been reported to contain N-nitrosamine impurities. The investigation of these products has now been expanded to all chemically synthesised medicines including biologicals (excluding complementary medicines). This review is due to the detection of an impurity, N-nitrosodimethylamine (NDMA), in sartans, metformin, ranitidine and rifapentine, which was found to be above the acceptable intake limit. NDMA is classified as a probable human carcinogen and SAHPRA is therefore investigating its levels (and any other N-nitrosamine impurities) in all new and already registered chemically synthesised medicines including biologicals and products in the pre-registration phase. SAHPRA’s plan of action for nitrosamine review can be accessed here.
SAHPRA aims to implement a unique product identification and medicine monitoring system for all medicines registered in South Africa by adopting the ISO/IEC 15416:2016 and ISO/IEC 15415:2016 standards, which stipulate the methodology for the measurement of specific attributes of barcode/data matrix symbols together with GS1 standards for product identification, data capture and data exchange. By implementing unique product identification and barcoding, SAHPRA intends to improve transparency and increase efficiencies across the medical products supply chain. A phased implementation approach is being taken, starting with batch-level identification and moving towards unit/product-level serialisation. The deadline for comments is 30 June 2024. Click here to read the Guidelines on the Traceability of Health Products. Using this comments form, you can submit comments to christelna.reynecke@sahpra.org.za
No national medicines regulatory authority (NRA), regardless of its maturity level, has adequate resources to evaluate marketing authorisation applications and issue a regulatory decision without relying on evaluations performed by another NRA. Bearing this in mind, reliance has been adopted by regulators across the world and is encouraged. "Reliance” is the term used to describe the process by which a regulatory authority in one jurisdiction may consider and give significant weight to – i.e. totally or partially rely upon – evaluations performed by another regulatory authority or trusted institution in reaching its own decision. The relying authority remains responsible and accountable for decisions taken, even when it relies on the decisions and information of others.
The Medicines Control Authority of Zimbabwe (MCAZ) is using reliance as one solution to its resource limitations which make it challenging to evaluate specialised aspects of novel products. Its recently published reliance policy can be accessed here.
Similarly, SAHPRA has adopted the reliance review approach as a pathway for registration of medicines, and harmonised some of its medicine policies and procedures with those of the European Medicines Agency (EMA). SAHPRA’s approach allows it to leverage evaluations performed by recognised regulatory authorities that it aligns with, in order to make its evaluation process more efficient and enhance market access. Download the latest version of the SAHPRA reliance guideline here.
On 14 February 2024, Cote d’Ivoire adopted a decree ratifying the Treaty for the Establishment of the African Medicines Agency. On 15 May 2024, the country then deposited its instrument of ratification, which brings to 29 the number of African countries that have ratified the AMA treaty. The 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 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 Harmonisation (AMRH) initiative, which was established in 2009, and is currently led by AUDA-NEPAD.
On 20 May 2024, the Ethiopian Food and Drug Authority (EFDA) released a letter outlining safety concerns related to the use of ranitidine and requested the Ethiopian community to discontinue use of the product. The product is banned due to high levels of NDMA found in randomly sampled ranitidine in the market. In the products tested, NDMA was discovered to be as high as 12 times the acceptable limit. The Namibia Medicines Regulatory Council (NMRC) also implemented the same measure, and it announced on 14 May 2024 that ranitidine containing products will no longer be used in the country due to the NDMA content.
The Pharmacy and Poisons Board of Kenya (PPB) issued an alert about a confirmed counterfeit batch of Herceptin 440mg (Trastuzumab 440mg). Herceptin is used for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes or is HER2-positive and has not spread into the lymph nodes. The counterfeit batch has batch number C5830083 and claims to be manufactured by Roche in Germany. The manufacturing date is 12/2021 and the expiry date is 11/2024.
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