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Welcome to the February 2024 edition of this newsletter, where we bring you the latest news, events and achievements from our Regulation and Prequalification (RPQ) Department as we strive to improve access to safe, effective and quality-assured medicines around the world.
Recent highlights
High-level joint meeting on strengthening the regulatory system and harmonization in Africa
The experience during the COVID-19 pandemic prompted the African Union (AU) to commit to producing 60% of vaccines needed across the continent by 2040. To explore and agree on key priorities and approaches to achieve this ambitious goal, a high-level policy meeting was convened by Africa Centres for Disease Control and Prevention (Africa CDC), African Union Development Agency’s New Partnership for Africa’s Development
(AUDA-NEPAD) and WHO from 12 to 13 February in Addis Ababa, Ethiopia. The meeting was joined by the Regional Director and other representatives from WHO AFRO, the Director-General of Africa CDC, the CEO of AUDA-NEPAD, representatives from WHO EMRO, the Director of WHO Department of Regulation and Prequalification and his senior leadership team, heads and representatives of national regulatory authorities (NRA) from Ghana, Kenya, Morocco, Nigeria, Senegal, South Africa, Tanzania and Tunisia, as well as global partners and funders.
The meeting resulted in a common understanding and consensus that local production of quality-assured medical products must comply with international safety, quality and efficacy standards; enhancing efforts for regulatory systems strengthening of NRAs, networking and harmonization of regulatory requirements as critical immediate steps; and all stakeholders and partners to take integrated collaborative actions to achieve this ambitious goal.
WHO, at the three levels, is committed to providing the required technical support to facilitate the realization of the ambitious AU target.
Assisted self-benchmarking of blood regulation in Serbia
The WHO Regulatory Systems Strengthening Team, in collaboration with the Blood, Blood Products and Products of Human Origin Team, assisted Serbia with self-benchmarking from 30 January to 1 February. The self-benchmarking was conducted using the evaluation of national regulatory systems of blood products which includes whole blood, blood components and plasma-derived products. This took place alongside other collaborative activities, including a planned formal re-benchmarking of the vaccine and medicine regulatory system. As the outcome of this mission, the formal blood products benchmarking is planned for 2025.
Facilitating access to vector control products through Collaborative Registration Procedure
A milestone has been reached with the hybrid kick-off meeting of the Collaborative Registration Procedure (CRP) for vector control products (VCP) in Arusha, Tanzania, between 30 January and 1 February. The participants in the meeting were representatives from the national regulatory authorities (NRAs) of the five pilot countries (Ghana, Kenya, Nigeria, Rwanda and Tanzania) from Innovation to Impact; WHO Facilitated Product Introduction; and the Prequalification Unit Vector Control Product Team. The meeting focused on processes and draft CRP VCP guidelines, the management of local efficacy trials, a proposed template for NRA assessment, inspection aspects and post-registration management, among other topics. The selected pilot product (an insecticide-treated net) will be submitted in February and the pilot will be finalized by July.
Prioritizing pharmacovigilance activities for 2024 with Uppsala Monitoring Centre
A second planning meeting between the WHO Pharmacovigilance team and the Uppsala Monitoring Centre (the WHO Collaborating Centre for International Drug Monitoring) took place from 12 to 13 February in Geneva, Switzerland. The objective was to prioritize pharmacovigilance activities for 2024, per the WHO 14th General Programme of Work and the RPQ action plan. The meeting identified key priorities requiring support from the Uppsala Monitoring Centre in 2024, along with collaborative pharmacovigilance projects spanning the three levels of WHO.
Session on quality assurance of in vitro diagnostics at the 2023 African Society for Laboratory Medicines conference
WHO, in collaboration with The Global Fund, Unitaid, USAID and PATH, organized a satellite session focused on quality assurance of in vitro diagnostics (IVDs) with particular emphasis on the African Region during the 2023 African Society for Laboratory Medicines conference, held from 12 to 15 December 2023 in Cape Town, South Africa. The session brought together key partners investing in and implementing quality assurance of IVDs, including representatives from manufacturers and laboratory personnel, and shared information on quality assurance mechanisms and policies across donor agencies.
Building on the success of in vitro diagnostics pilot assessment
From June to December 2023, the Prequalification Unit In Vitro Diagnostics Assessment Team (PQT-IVD) piloted a new assessment model whereby assessors meet to work in teams for a week reviewing product dossiers and change requests. Four assessment sessions were held in Geneva, Switzerland, bringing 31 technical experts and participants from 10 different national regulatory authorities, to leverage IVD knowledge and experience. Key objectives of the pilot were to assess product applications, share expertise among assessors, strengthen prequalification assessment capacity and develop a robust workplan for future sessions. The pilot phase demonstrated increased efficiency in completing dossier and change request reviews while ensuring a standardized assessment against prequalification requirements. Feedback from the participants also allowed the development of an effective session format to maximize future productivity. In 2024, further meetings are planned to complement the PQT-IVD team’s overall assessment process and support the timely delivery of IVD assessments.
New tools and resources
WHO Biomanufacturing Workforce Training Initiative
The Local Production and Assistance Unit launched the WHO Biomanufacturing Workforce Training Initiative website to assist countries in building workforce capacity for local production of biological products such as vaccines and cancer medicines. The WHO Biomanufacturing Workforce Training Initiative aims to provide accessible and systematic training, based on WHO and international norms and standards, and tailored to each country’s or region’s needs. Read more
Trends in falsified medicines: diabetes type II and weight loss products
Since early 2023, an increasing number of reports on falsified glucagon-like peptide 1 receptor agonist (GLP-1-RA) have been flagged to the WHO Global Surveillance and Monitoring System. GLP-1-RA products are most commonly used to manage diabetes type II, but are also sought for weight loss. A surge in demand associated with an extended shortage has partially triggered the increase in falsified products, many of which are supplied through unauthorized outlets, including social media platforms. Falsified medicines may lack efficacy or cause toxic reactions. While WHO continues to monitor the situation, proactive market surveillance by national regulatory authorities (NRA) is recommended. Incidents of substandard or falsified medical products should be reported to the relevant NRA who then notifies WHO through the focal point network.
Prequalification Public Assessment Reports
29 January
CV017
Nirmatrelvir + Ritonavir: 150 mg + 100 mg – Tablet, Film-coated + Tablet, Film-coated.
Celltrion Inc., Republic of Korea.
26 January
BT-EB002
Atoltivimab/Maftivimab/Odesivimab: 33.33 mg/mL/33.33mg/mL/33.33mg/mL – Solution for infusion.
Regeneron Pharmaceuticals Inc., United States of America.
BT-EB001
Atoltivimab/Maftivimab/Odesivimab: 16.67 mg/mL/16.67 mg/mL/16.67 mg/mL – Solution for infusion.
Regeneron Pharmaceuticals Inc., United States of America.
TB401
Pyridoxine hydrochloride: 50mg – Tablet, Film-coated.
S Kant Ltd, India.
TB396
Bedaquiline fumarate: 100 mg – Tablet.
Lupin Ltd, India.
MA170
Pyrimethamine/Sulfadoxine+Amodiaquine (hydrochloride): 12.50 mg/250 mg + 76.5 mg – Tablet, Dispersible + Tablet, Dispersible.
Macleods Pharmaceuticals Ltd, India.
MA171
Pyrimethamine/Sulfadoxine+Amodiaquine (hydrochloride): 25 mg/500 mg + 153 mg – Tablet, Dispersible + Tablet, Dispersible.
Macleods Pharmaceuticals Ltd, India.
MA168
Arginine Solvent for parenteral use + Artesunate (sterile): 20 mg/ml + 60 mg – Powder for solution for injection.
Guilin Pharmaceutical Co. Ltd, China.
HP002
Sofosbuvir: 400 mg – Tablet, Film-coated.
Hetero Labs Ltd, India
HA779
Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine: 60 mg/5 mg/30 mg – Tablet, Dispersible.
Cipla Ltd, India.
WHO Pharmaceuticals Newsletter: No. 1, 2024
The WHO Pharmaceuticals Newsletter provides the latest information on the safety of medicinal products and regulatory actions taken by authorities worldwide. This edition includes the recommendations from the Pharmacovigilance Meeting of the Members of the WHO Programme for International Drug Monitoring and Partners in Africa, March 2023. Read the newsletter
Prequalification: latest updates
Stay up to date with the latest prequalification news – from public assessment reports to prequalification lists and sector events – at WHO’s Prequalification of Medical Products page.
Get involved
Calls for Expressions of Interest: prequalification of capillary blood glucose monitoring systems and HbA1c point-of-care analysers
Technical Specification Series (TSS) documents are developed to guide manufacturers on the types of analytical and clinical performance data required for WHO Prequalification assessment.
TSS 18: Haemoglobin A1c point-of-care analysers for professional use. Read the guidance
TSS 19: In vitro diagnostic medical devices for monitoring of blood glucose in capillary blood. Read the guidance
For more information, contact: diagnostics@who.int.
