As we approach the end of March, we are energized by the opportunities ahead and proud of the progress we continue to achieve together. This month, we highlight key initiatives, share important updates and celebrate the impact of our collective efforts. From innovative projects to strategic partnerships, our work continues to drive meaningful change globally. In this edition, you'll find insights into current activities and updates on upcoming events, reflecting the dedication and innovation within our regulation and prequalification community. Your collaboration and commitment remain at the core of our success, and we are grateful for your continued support. Thank you for being part of this journey. We look forward to another month of progress, collaboration and impact.

Inspection Services

WHO Inspection Services and WHO Laboratory Network and Services play a vital role in strengthening national quality control laboratories (NCLs) and ensuring compliance with WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL). In February 2025, both teams jointly conducted three NCL inspections: Drug Testing Laboratory in Bahawalpur, Pakistan; Central Drugs Laboratory in Karachi, Pakistan; and Laboratoire National de Contrôle des Médicaments in Rabat, Morocco, following the reorganization of Morocco’s regulatory system and the establishment of the Agence Marocaine des Médicaments et des Produits de Santé. In addition, to address the global Rifampicin shortage, Inspection Services expedited the inspection of an active pharmaceutical ingredient manufacturer, ensuring timely access to this critical tuberculosis and leprosy treatment. 

Photo: WHO

In Vitro Diagnostics

On 6 March 2025, WHO listed a fourth MPXV in vitro diagnostic (IVD) under the WHO Emergency Use Listing (EUL) Procedure. The RADIONE Mpox Detection Kit, manufactured by KH Medical Co., Ltd., is an automated PCR test designed to detect MPXV DNA (clade I and clade II) in skin lesion specimens from patients with suspected monkeypox infection. The kit is used with the RADIONE Universal DNA/RNA Extraction Kit on the RADIONE instrument for accurate results. The list of WHO-EUL IVDs can be found here. WHO continues evaluating MPXV IVDs to expand access to quality-assured tests. The status of active EUL applications is available here.

Photo: WHO / Katson Maliro

Medicines

Medicine is expanding its collaboration with the African Medicines Agency, engaging experts in medicine assessment sessions, the 17th annual assessment training in June, and a dedicated three-day hands-on training. Medicines has also published new invitations for manufacturers of dispersible formulations of azithromycin, nitrofurantoin, and amoxicillin to improve treatment options for bacterial infections in children. Additionally, the first invitation to manufacturers of Mycobacterium tuberculosis antigen-based skin tests to submit dossiers has been issued. Finally, the zinc product submission guidelines for diarrhoea treatment have also been revised to 5mg tablets, following evidence that a lower dose maintains efficacy while improving tolerability.

Photo: Stock image

Vaccines

On 12 March 2025, WHO prequalified the first maternal RSV vaccine, ABRYSVO®, to protect infants from acute lower respiratory infections by transferring antibodies during pregnancy. It is manufactured by Pfizer, with the European Medicines Agency as the national regulatory authority (NRA). This milestone aims to expand RSV vaccination in low- and lower-middle-income countries most at risk of severe disease.
WHO also prequalified a trivalent seasonal influenza vaccine, manufactured by the Federal Medical and Biologic Agency in the Russian Federation. The Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos is the NRA.

Photo: WHO / N. Thomas

Vector Control Products

In March, VCP prequalified four new insecticide-treated nets (ITNs), expanding vector control tools and local production opportunities.The PRONet Duo is a dual-active ingredient ITN containing chlorfenapyr and is the first ITN formulated with the pyrethroid bifenthrin. UNET G1 (deltamethrin), UNET G3 (deltamethrin + PBO) and UNET G5 (alpha-cypermethrin + chlorfenapyr) are new products using treated fabrics of existing prequalified products as starting materials with finishing production in Africa. These approvals enhance procurement and distribution efforts, supporting malaria control with more locally produced products. The average WHO prequalification time for these ITNs was 116 days (182 calendar days/66 manufacturer days), reinforcing WHO’s commitment to timely access to innovative vector control products.

Regulatory Systems Strengthening

WHO continues to advance regulatory systems strengthening. A high-level mission to Pakistan engaged national health authorities and resulted in a revised roadmap to benchmark the national regulatory system by mid-2026. WHO emphasized improved interprovincial coordination, greater participation in global surveillance mechanisms, and reinforced the importance of compliance with Good Manufacturing Practices (GMP). In Côte d'Ivoire, a pre-benchmarking assessment showed progress toward Maturity Level 3, with follow-up actions planned. In Benin, WHO reviewed progress on the Institutional Development Plan and developed an updated plan. Additionally, WHO hosted a regional workshop in Sri Lanka to improve medical device regulation in South-East Asia, focusing on self-benchmarking, reliance mechanisms and post-market surveillance to expand access to quality-assured medical products.

Photo: WHO

Facilitated Product Introduction

WHO’s Collaborative Registration Procedure (CRP) continues to grow, with 13 new NRAs joining since March 2024. New participants include Brunei Darussalam, El Salvador, Montenegro, Paraguay, Philippines, Qatar, Saudi Arabia, Serbia, Tunisia, The Gambia, and Sri Lanka, expanding CRP’s global reach to 68 countries and one regional economic community. To date, over 1470 registrations have been processed through CRP, enhancing regulatory efficiency and informed reliance. In September 2024, WHO launched the Facilitated Procedure for Emergency Use Listing (EUL) MPXV Assays, accelerating monkeypox test approvals. Ghana, Kenya, Senegal, South Africa and Uganda have signed on, with three authorizations already granted. Additional countries are encouraged to participate. Contact the Facilitated Product Introduction team for additional information.

Photo: WHO / Felix Marquez

Laboratory Networks and Services

The WHO Laboratory Networks and Services team hosted three awareness events to promote membership in the WHO Global Network of Quality Control Laboratories (WHO-GNP) and the WHO National Control Laboratory Network for Biologicals (WHO-NNB). Over 250 participants from more than 70 countries engaged in discussions, leading to 11 laboratories and one country expressing interest in joining WHO-GNP and WHO-NNB. This advocacy initiative successfully expanded awareness and participation, strengthening global pharmaceutical and biological quality control efforts.

Photo: WHO

Incidents and Substandard / Falsified Medical Products

The Steering Committee of the Member State Mechanism met at WHO headquarters from 11–14 March 2025 to review strategic priorities, including the 2025 activity budget, funding gaps and WHO medical product alerts. Discussions covered WHO medical product alerts (e.g. nitazene contamination), the Global Surveillance and Monitoring System and a new theory of change and results framework. The Secretariat also presented follow-up actions on the management response to the recommendations from the external evaluation. The next meeting is scheduled for 23–25 July. WHO also issued Medical Product Alert N1/2025, warning of falsified OXYCONTIN 80mg in Switzerland containing dangerous synthetic opioids. WHO urges healthcare professionals and the public to report suspected cases, avoid unregulated opioids, and seek immediate medical help if adverse effects occur.

Photo: WHO

Medicines 17th annual assessment training, June 2025

Incidents and Substandard / Falsified Medical Products Steering Committee of the Member State Mechanism, 23–25 July 2025