WHO Regulation and Prequalification Update
WHO Regulation
and Prequalification
UPDATE
May 2025
Message from the RPQ Director
I am delighted to share that our 2024 RPQ annual report is now available, showcasing a year of progress in making safe, effective health products accessible worldwide. In addition, our newly approved RPQ strategic action plan will be published soon and lays out a clear, measurable path toward regulatory excellence through 2030. Finally, we have launched the ePQS portal, giving manufacturers a single, secure gateway to submit and receive documents, including electronic Common Technical Document dossiers (eCTD) and track every stage of the prequalification journey. These milestones mark a major step toward faster innovation and stronger public health oversight.
Photo: WHO
Communication tools
WHO’s Coordinated Scientific Advice (CSA) procedure is accelerating innovation by bringing policy and prequalification experts together early in product development. Through tailored guidance on study design and regulatory expectations, CSA helps developers refine late-stage trials, strengthen dossier quality and shorten the road from laboratory to patient. The result is quicker access to priority diagnostics, medicines, vaccines and vector control tools that already meet WHO standards at submission. A new video illustrates how CSA is shaping a smarter pipeline for global health breakthroughs and invites developers to engage with the process from the outset.
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
WHO’s Inspection Services team has completed a comprehensive audit of one of the world’s largest vaccine manufacturers, examining new applications for prequalification as well as additional facilities for already listed products. The mission verified compliance with current Good Manufacturing Practices (GMP) across a portfolio that includes polio, rotavirus, diphtheria-tetanus (DTP), influenza, measles, mumps and rubella (MMR), meningococcal and COVID-19 vaccines, expanding global supply capacity while safeguarding quality. A rotational inspector from Rwanda FDA joined the team, gaining hands-on experience.
Photo: WHO
In Vitro Diagnostics
WHO has added three new IVDs to the list of prequalified products, including the first urine-based HIV test. To bolster outbreak preparedness, three more MPXV IVDs have been listed under the Emergency Use Listing (EUL), raising the total to six. Revised guidance on reportable changes for prequalified and EUL-listed IVDs is now available, supported by a dedicated webinar. Reflecting market needs, the Prequalification Programme’s scope has expanded to cover haemoglobin point-of-care analyzers.
Photo: WHO / A. Craggs
Vector Control Products
Responding to manufacturer feedback, the Vector Control Products team has expanded its Advice to Manufacturers Series, publishing seven new briefs in 2024 and two more (so far) in 2025. The latest documents provide clarification on the differences between WHO specifications versus manufacturing release specifications, and guidance on the inclusion of analytical bridging studies in prequalification dossiers. These guides help applicants assemble stronger submissions, reducing review cycles and accelerating product access for prevention of malaria and other vector-borne diseases worldwide. Manufacturers and other stakeholders are invited to suggest future topics by email or during the Wednesday Webinars, ensuring the series grows in step with evolving industry needs and stakeholder priorities.
Photo: WHO / S. Torfinn
Regulation and Safety
Regulation and Safety focuses on building effective and efficient regulatory systems to protect public health and ensure timely access to quality medical products. Aligned with WHO’s strategic plan, this work supports WHO Member States by strengthening national and regional regulatory frameworks, increasing preparedness for public health emergencies and expanding WHO prequalification processes. By facilitating collaboration among stakeholders, Regulation and Safety aims to enhance regulatory practices, ultimately promoting universal health coverage and improving global health outcomes.
Regulatory Systems Strengthening
WHO experts travelled to the United Republic of Tanzania to enhance the inspection capacity of the Tanzania Medicines and Medical Devices Authority (TMDA). Thirty-three inspectors benefited: six participated in a WHO-led GMP coached audit, while 27 joined an advanced GMP workshop that reinforced technical competencies and regulatory practices. This mission forms part of WHO’s ongoing efforts to support regulatory system strengthening across Africa and to foster resilient, mature and sustainable national regulatory systems.
Photo: WHO
Laboratory Networks and Services
From 20–22 May 2025, WHO’s Laboratory Networks and Services team completed a preliminary audit of the National Center for Quality Control in Peru – the first such mission in the Americas conducted entirely in Spanish. This mission was part of the WHO prequalification process for pharmaceutical quality control laboratories. Three observers from national control laboratories in the Americas joined through the new RPQ training catalogue, fostering peer exchange and hands-on learning.
Photo: WHO
Incidents and Substandard / Falsified Medical Products
Two upcoming technical briefings will spotlight national strategies to detect and prevent substandard and falsified medicines. On 27 May 2025, 13:00–14:00 CET, a new report documenting national experiences in implementing traceability systems will be presented. On 29 May 2025, 10:30–12:00 CET, experts will share how pooled knowledge and screening technologies expose poor-quality products. To register or request the report, please email sandsa@who.int.
Photo: WHO / Sergey Volkov
Cross-cutting initiatives
Knowledge Management
RPQ launched the Health products regulation and prequalification learning catalogue to support countries in strengthening systems that ensure the safety, quality and effectiveness of health products. This newly launched catalogue serves as a centralized hub, offering easy access to a wide range of RPQ learning opportunities – including self-paced e-learning courses, instructor-led sessions and on-the-job training experiences – available in multiple languages and fully searchable for target audiences.
Photo: Anastasiia Gudantova on Unsplash
ePQS Portal
The new ePQS portal is now live, providing manufacturers with a single, secure gateway to create and submit prequalification applications, upload supporting documents, and track decisions in real time. Built on a unified data and document management system spanning every Prequalification team, ePQS includes an eCTD[1] repository and guided application wizards that walk users through each step. External users can download the registration form from the landing page and request access today. By digitizing the end-to-end workflow, ePQS ensures quicker reviews, clearer correspondence and a transparent path from dossier to listing.
Photo: WHO
[1] eCTD or electronic Common Technical Document format allows for the electronic submission of the Medicine and Vaccine information in Common Technical Document (CTD) from the applicant to regulator. https://ich.org/page/ich-electronic-common-technical-document-ectd-v322-specification-and-related-files
