WHO Regulation and Prequalification Update
WHO Regulation
and Prequalification
UPDATE
June 2025
Message from the RPQ Director
On 6 June, 120 members of the Department of Regulation and Prequalification came together on the WHO campus for a full-day retreat—the first step in translating our new RPQ Strategic Action Plan 2025–2028 into concrete results for the 2026–2027 biennium. Through lively breakout and plenary discussions, we reaffirmed our shared commitment to continuity and stability while charting bold ways to accelerate equitable access to quality-assured medical products and to strengthen robust, resilient and reliable regulatory systems. Above all, we agreed that a people-centred approach must drive every system-centred outcome we pursue.
This edition of the RPQ update showcases the progress each team is already making toward our collective goals. I encourage you to read it closely and share it with your networks. Thank you for your dedication and partnership in turning our shared strategy into real-world impact.
Photo: WHO
RPQ mandate
To help Member States develop robust, resilient and reliable regulatory systems through a variety of approaches and to ensure medicines, vaccines and other health products for supply to low‑income countries are quality-assured, safe, effective and accessible to all populations.
Prequalification
The WHO Prequalification Programme aims to ensure that key health products meet global standards of quality, safety and efficacy. This helps optimize the use of health resources and improve health outcomes.
Inspection Services
Vector-borne diseases cause 17 % of the global communicable-disease burden and over 700 000 deaths each year. WHO Prequalification’s Vector Control Product (PQT/VCP) team safeguards the quality of insecticide-treated nets, indoor residual sprays, larvicides and other critical tools. PQT Inspection Services audit manufacturers against ISO 9001:2015 and WHO requirements, ensuring products remain safe, effective and reliable. In May 2025, inspectors from PQT Inspection Services and the VCP Assessment Team visited an insecticide-treated net manufacturing site in China.
Photo: WHO
In Vitro Diagnostics
WHO has released a Q&A document to clarify the updated Change Request (CR) process for in vitro diagnostics (IVDs) listed under Prequalification or the Emergency Use Listing. The FAQ walks applicants through the new CR form, explains which changes must be reported, and outlines the risk‐based criteria used to categorize each change. It also indicates when a significant change triggers a brand-new application and highlights how WHO leverages regulatory reliance to streamline assessments. This practical resource aims to improve communication with manufacturers and ensure timely, fully compliant submissions under the updated guidance. Access: guidance document and webinar.
Photo: WHO
Medicines
WHO’s Medicines Prequalification Team (PQT/MED) has published a guidance note – now open for comment – explaining how it will work with WHO-Listed Authorities and ML3/4 national regulators during product prequalification. In May, PQT/MED ran its first post-pandemic virtual assessment session, drawing on lessons from earlier remote work. Two regulator-focused assessment trainings followed on 9–13 June: a four-day course on small-molecule medicines and a one-day module on biotherapeutics, attracting nearly 700 participants from national regulatory authorities. Planning is under way for a virtual September training tailored to assessors linked to the African Medicines Agency, complemented by rotational fellowships at WHO headquarters in 2025.
Photo: Stock image
Vaccines
WHO has prequalified COVOVAX, a recombinant adjuvanted XBB.1.5 vaccine manufactured by Serum Institute of India, bringing the number of prequalified COVID-19 vaccines to three. Supplied in single-dose vials, it has a shelf life of nine months at 2–8 °C and is indicated for active immunization against SARS-CoV-2 in people aged 12 years and older. WHO continues to recommend COVID-19 vaccination for four groups: (1) older adults at higher risk; (2) individuals > 6 months old with moderate-to-severe immunocompromise; (3) pregnant adults and adolescents; and (4) health workers. Vaccination remains a critical public health countermeasure.
Photo: WHO / N. Thomas
Vector Control Products
The 24th Joint Meeting on Pesticide Specifications (JMPS) convened in Galway, Ireland, 11–14 June 2025. Acting as Secretariat, FAO and WHO brought together expert panelists to review 28 manufacturer submissions and recommend whether WHO/FAO pesticide specifications should be adopted, extended, modified or withdrawn. The group evaluated 16 applications for new active-ingredient (AI) specifications, 10 applications for extension of specifications – including impurity-profile checks – and two applications for changes to established specifications. JMPS specifications set global norms for identifying and quality-controlling technical materials and formulations, giving regulators a trusted reference for safeguarding public health.
Photo: WHO
Regulation and Safety
Regulation and Safety work focuses on building effective and efficient regulatory systems to protect public health and ensure timely access to quality medical products. Aligned with the Department’s Regulatory Action Plan, this work supports WHO Member States by strengthening national and regional regulatory frameworks, increasing preparedness for public health emergencies and enhancing systems for prevention, detection and response to SF medical products and adverse events or reactions. By facilitating collaboration among regulatory authorities and with stakeholders, Regulation and Safety Unit aims to enhance regulatory practices, ultimately promoting universal health coverage and improving global health outcomes.
WHO representatives, led by the Unit Head for Regulation and Safety, joined the African Medicines Agency (AMA) Governing Board and European Medicines Agency (EMA) Management Board in Amsterdam on 11–12 June. The high-level dialogue gathered the AMA Director-General Designated, Delese Mimi Darko, heads of leading African regulatory authorities, the African Union Commission, AUDA-NEPAD, and European Heads of Medicines Agencies. The meeting addressed the most pressing issues faced by a regional regulatory agency, including the management of scientific and financial resources, regulatory information management, stakeholder engagement, and lessons learned from the EMA’s journey. WHO reaffirmed its commitment to help operationalize AMA as a trusted African Union agency that improves equitable access to quality-assured medical products across Africa.
Photo: H. Sillo and D.M. Darko
Regulatory Systems Strengthening
WHO facilitated a workshop in Viet Nam to help national regulators develop and implement Regulatory Performance Indicators (RPIs). Approximately 35 participants from the Drug Administration of Viet Nam, the National Institute of Drug Quality Control, the National Institute for Control of Vaccines and Biologicals, and the Hanoi and Ho Chi Minh City health departments collaborated to tailor RPIs across key regulatory functions. Feedback was positive, with attendees gaining valuable insights into effective indicators to enhance regulatory performance.
Photo: WHO
Regulatory Convergence and Networks
WHO’s Regulatory Convergence and Networks (RCN) team has coordinated a new publication, WHO Certification Scheme on the Quality of Pharmaceutical Products. It reflects a collaborative effort involving: WHO; national regulatory authorities; Cuba’s Center for State Control of Medicines, Equipment and Medical Devices; the European Medicines Agency (EMA); the Health Sciences Authority; and industry stakeholders represented by IFPMA. It explores the scheme’s aims and evolution with a focus on country-level implementation. RCN also advanced global harmonization by representing WHO at the International Council for Harmonisation meetings and at the 15th Management Committee Meeting of the International Pharmaceutical Regulators Programme.
Photo: WHO
Facilitated Product Introduction
Two Collaborative Registration Procedure (CRP) webinars broadened the uptake of WHO-prequalified products. The first engaged more than 110 IVD manufacturers, explaining enrolment steps and highlighting the recent surge in CRP registrations. The second gathered nearly 60 regulators and manufacturers to launch CRP for VCPs, share the final guidelines and showcase a pilot that already enabled three national approvals, including Ghana FDA’s in just 28 working days. In addition, to strengthen regulatory capacity, a new self-paced WHO Academy course, Basic fundamentals of IVD medical devices regulation – a global approach, was launched and offers six modules covering quality systems, risk assessment, market approval and post-market surveillance, with certificates on completion.
Photo: WHO
Laboratory Networks and Services
Since launching the ePQS portal on 19 May, the Laboratory Networks and Services team has fully digitized its quality control laboratory (QCL) prequalification (PQ) and post-PQ processes. Early results include 47 annual reports submitted through ePQS, 54 of 64 prequalified QCLs onboarded, two new PQ applications received, and one request for technical assistance. This digital shift streamlines interactions with QCLs and improves efficiency, traceability and transparency throughout the PQ process.
Photo: WHO
Pharmacovigilance
The Pharmacovigilance team published the Protocol on estimation of Guillain-Barré syndrome background rates in general populations of low- and middle-income countries. Establishing these background rates is critical for interpreting potential safety signals following vaccine introduction and for strengthening global vaccines safety monitoring systems. Protocols on thrombocytopenia and neonatal outcomes are forthcoming, with pilot implementation planned in selected countries.
In addition, WHO, in collaboration with Germany’s Paul-Ehrlich-Institut, convened a Risk Management Plan (RMP) assessment workshop at WHO headquarters, introducing Model RMP Assessment Tools to regulators from Ghana, Rwanda, Sierra Leone and Zimbabwe. Participants piloted the tools developed by WHO and their feedback will inform tool finalization.
Photo: WHO
Incidents and Substandard / Falsified Medical Products
WHO issued Medical Product Alert N°3/2025 after three falsified batches of IMFINZI (durvalumab 500 mg/10 mL) were detected. These falsified injections contain no active ingredient, posing a serious risk of ineffective or delayed treatment, and potentially life‑threatening outcomes. AstraZeneca has confirmed the discrepancies. WHO urges regulators, healthcare providers, and patients to remove any suspect batches, verify authenticity, and report suspicious products immediately.
To strengthen prevention and response, regulatory authorities and partners in the African region met in Nairobi to strengthen surveillance, risk communication and multi-sector collaboration against substandard and falsified (SF) products, with exercises on digital and AI-enabled detection. In addition, working groups of the WHO Member State mechanism on SF medical products helped launch a report documenting national experiences in implementing traceability systems for medical products and a report of the current technologies to screen and detect poor-quality and falsified medicines. WHO guidance on this topic is forthcoming, publication is expected 2026. WHO calls for experts to support development of a target product profile for the ideal device to screen for SF medicines. For more information, contact sandsa@who.int.
Photo: WHO
Cross-cutting initiatives
Quality Management Systems
Over the next few months, RPQ will carry out its next round of internal audits. Two internal QMS auditors will assess each team. While the previous cycle examined one new standard operating procedure (SOP) per team, this round will focus on how those SOPs are being implemented. Auditors will review a sample of related processes, evaluate how the procedures connect and check their practical application. They will also identify any gaps, duplications, or potential sources of error.
Photo: AI-generated image
ePQS Portal
WHO has received its first dossiers in electronic Common Technical Document (eCTD) format through the new ePQS applicant portal. The inaugural submissions were a vaccine PQ file from Serum Institute of India and an active pharmaceutical ingredient (APIs) application from Zhejiang Haizhou Pharmaceutical (also the first eCTD filing by a Chinese manufacturer). The ePQS portal guides applicants for APIs, finished pharmaceutical products, IVDs, immunization devices, vaccines and VCPs by application wizards to create and submit applications. This includes the uploading of related documents in a secure manner and for the submission of documents in eCTD format.
Photo: WHO
