Regulatory Spotlight - 01
August 9, 2024
Showcasing the latest developments, news and updates from African national medicines regulatory authorities.
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In Nigeria, the Central Drug Control Laboratory (CDCL) is the official reference laboratory for medicines under the National Agency for Food and Drug Administration and Control (NAFDAC), the national medicines regulatory authority of Nigeria. CDCL was inspected by the World Health Organization (WHO) from 15 – 17 February 2023 and an announcement was made by NAFDAC in mid-December 2023, confirming that the lab had been granted WHO Prequalification status. The official recognition by WHO means the lab meets international standards of excellence in medicines quality control and regulation. The lab will, among other duties, play a critical role in ensuring that substandard and falsified medical products are not circulating in the country, ultimately safeguarding public health. The WHO inspection report can be accessed here.
On 12 January 2024, the South African Health Products Regulatory Authority ty (SAHPRA) announced that it has signed a memorandum of understanding with the Medicines Control Authority Of Zimbabwe (MCAZ). The MoU will allow the regulatory authorities to develop a cooperative partnership towards ensuring access to quality-assured, safe and efficacious health products in the two countries. This partnership will focus on joint product reviews and inspections, as well as detection and curbing substandard and falsified medical products moving between the two countries. The SAHPRA media release can be accessed here.
The Tanzania Medicines and Medical Devices Authority (TMDA) published a reminder on 10 January 2024, directed at all Marketing Authorisation Holders (MAHs), informing them that according to sub-regulation 16 of the Tanzania Medicines and Medical Devices (Registration of Medicinal Products) Regulations, 2015, the deadline for payment of annual retention fees is 31 January 2024. Therefore, with effect from 1 February 2024, TMDA shall be compelled to suspend the registration of all products that have not been paid for in line with Section 55 (1) (b) of the Tanzania Medicines and Medical Devices Act, Cap. 219 and sub-regulation 19 (e) of the Tanzania Medicines and Medical Devices (Registration of Medicinal Products) Regulations, 2015. After suspension, the MAH shall not be able to import or market the said product. The Authority shall also ensure that the product is not allowed to circulate in the market until the retention fee and its penalty are paid. MAHs are encouraged to make payments before the stated deadline.
The National Agency for Food and Drug Administration and Control (NAFDAC) recently launched the NAFDAC Greenbook, a comprehensive database of medical products approved for sale and distribution in Nigeria. The Greenbook, which aims to promote transparency and drug safety, has approximately 7,030 entries thus far and is still growing. Accessible online or using a mobile application (Google Play Store or App Store), the Greenbook provides information such as medicine names, strengths, dosage forms, route of administration, ATC classification and other marketing authorisation details. This is a commendable initiative that will assist healthcare professionals, patients and the public to have accurate and reliable information - at their fingertips - about the medicines circulating on the market.
Tchamdja and colleagues conducted a study to enable the Economic Community of West African States (ECOWAS)/ West African Health Organization (WAHO) medicines regulatory harmonisation Secretariat and relevant stakeholders to gain a better understanding of the level of awareness about the ECOWAS Joint Assessment Procedure (JAP), perceptions of its value to the pharmaceutical industry and the challenges being faced that are leading to low utilisation of the JAP. The authors found that pharmaceutical manufacturers are not opposed to using the ECOWAS JAP despite having high expectations of the initiative. The main challenge reported in the study is failure of ECOWAS member states and the regional bloc to comply with their timelines. Therefore, the authors recommend tracking timelines, regularly publishing results and holding predictable joint dossier assessment meetings. Additionally, the authors encourage the West African medicines regulatory harmonisation Secretariat to explore more sources to share information about the benefits of the JAP and make it known to manufacturers and other stakeholders. The full study can be accessed here.
Zazibona, a work-sharing initiative amongst 13 national medicines regulatory authorities in the Southern African Development Community (SADC), has been transitioning to a centralised process that will replace the previous procedure requiring submission of applications in at least two participating countries. Under the new centralised procedure, products will be submitted for joint review and the resulting recommendation can be used to support product applications in countries participating in the initiative. Stakeholders are invited to attend an orientation session on 8 February 2024 at 0930 CAT which will cover the submission process, timelines, payment methods and handling of queries. Following the orientation process, the online submission portal for applications will be launched on 12 February 2024. The first joint assessment session for the year will then be held from 26 February to 1 March 2024 with the aim of concluding pending applications. Read these and other Zazibona updates in Circular 1 of 2024.
The European Commission awarded to the European Medicines Agency (EMA) a grant of €10 million to support national and regional regulatory systems in Africa and the establishment of the African Medicines Agency (AMA). AMA, an African Union specialised agency, has the mandate to improve equitable access to quality-assured, safe and efficacious medical products on the continent. As it stands, the treaty to establish the continental regulator has been ratified by 27 countries. The support being offered by EMA includes sharing its experiences in pooling resources and efficiently and effectively coordinating regulatory work, ensuring implementation of international standards and best practices, accelerating information exchange and reducing administrative burden to ensure timely access to medicines. In addition, EMA will mobilise experts to support AMA in various aspects and offer trainings. Read the full news article here.
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