WHO Regulation and Prequalification Update
WHO Regulation
and Prequalification
UPDATE
July 2025
Message from the RPQ Director
As we approach the third quarter of 2025, our focus remains on the continued implementation of the Department’s Strategic action plan 2025–2028 – an effort grounded in collaboration, innovation, and shared commitment. In the coming months, we will work closely with partners, manufacturers, regulators and colleagues across WHO to advance our collective goals, ensuring that quality-assured health products reach the communities that need them most. Together, we are building systems that not only meet today’s public health needs but also lay the foundation for a healthier, more equitable future.
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
In June 2025, WHO Inspection Services reinforced its commitment to quality-assured health products through an inspection campaign in Asia. The team visited a quality control lab in Singapore, two pharmaceutical manufacturers in Indonesia, and Cambodia’s National Quality Control Laboratory (NQCL). In Cambodia, inspectors met with WHO Country Office staff, Ministry of Health officials, and lab representatives to discuss regulatory strengthening and the NQCL’s self-assessment using WHO’s Global Benchmarking Tool. In addition, WHO participated in the June Inter Agency Pharmacists Group (IAPG) meeting, hosted by the Global Fund, sharing updates on product quality issues, abridged prequalification pathways, procurement guidance and international alignment on Good Manufacturing Practices (GMP). IAPG members include the Global Fund, Global Drug Facility/Stop TB Partnership, ICRC, MSF, UNFPA, UNDP, UNICEF and WHO.
Photo: WHO
In Vitro Diagnostics
WHO has granted the first prequalification listing of a bundle of three diagnostics tests to be used for pregnant women for the qualitative detection of HIV, Hepatitis B surface antigen and Treponema pallidum syphilis antibodies in human capillary whole blood. All post-prequalification and emergency use listing change request applications for in vitro diagnostics (IVDs) must now be submitted exclusively via the ePQS portal. Applicants are advised to ensure their portal access is fully set up before submitting a new request. For assistance with account creation or technical issues, contact diagnostics@who.int. Applicants are also reminded that any changes in formulation, substitution or removal of reagent components that may affect the performance of a prequalified IVD, including those related to the implementation of the REACH Regulation, are considered reportable and must be submitted accordingly.
Photo: WHO
Vaccines and Immunization Device Assessment
As part of the Essential Programme on Immunization, WHO works to ensure universal access to safe and effective vaccines, including through the prequalification of vaccine vial monitors (VVMs). These labels change color based on cumulative heat exposure and are a simple, cost-effective tool to ensure only potent vaccines are used, particularly in hard-to-reach areas. With support from WHO’s China Country Office, a cross-departmental team from the Immunization Devices (ImD) and Inspection Services units inspected a VVM manufacturing site in China. As only the second manufacturer to apply for prequalification of VVMs, this inspection marks an important milestone. The ImD team welcomed the growing interest among manufacturers in pursuing prequalification of these critical devices.
WHO prequalified four COVID-19 vaccines and is in constant dialogue with the COVID-19 vaccine manufacturers to stay up to date with upcoming strain updates to the vaccine that will be assessed using the procedure for major variations.
Recent approvals include Nuvaxovid (JN.1) and a 2–8 °C formulation of Comirnaty® JN.1 (GREY CAP), enhancing cold chain flexibility. In addition, a bivalent oral polio vaccine (bOPV) for types 1 and 3 was prequalified, reinforcing efforts to eradicate remaining wild polio strains following the global transition from trivalent OPV.
Learn more (Immunization Devices)
Photo: WHO
Vector Control Products
WHO Vector Control Product Assessments Team (PQT/VCP) has launched a new Rotational Fellowship Programme, modeled after successful initiatives in the Medicines and Inspections teams. The fellowship offers regulators and scientific assessors, primarily from national regulatory authorities, an opportunity to strengthen their experience in dossier assessment and regulatory activities while working directly with the PQT/VCP team. Fellows contribute to the assessment of prequalification applications, development of dossier requirements for novel product types and creation of training materials to support national authorities. The programme supports stronger regulatory systems for vector control products and public health pesticides, while reinforcing collaboration between WHO and Member States. PQT/VCP is pleased to welcome its first fellow, Sharon Annison, Principal Regulatory Officer and Head of the Household Chemical Substances Unit at the Food and Drugs Authority of Ghana.
Photo: Sharon Annison
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 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.
Regulatory Systems Strengthening
WHO recently supported two key initiatives to strengthen regulatory systems for medicines and vaccines. From 15–19 June, Algeria conducted a self-benchmarking of its regulatory system with WHO staff and assessors, involving national authorities and key institutions such as ANPP, IPA, and the Ministry of Health. The review identified strengths and areas for improvement across nine core functions, leading to a revised roadmap toward Maturity Level 3 and the development of an Institutional Development Plan.
Simultaneously, WHO hosted a bi-regional workshop from 16–19 June to enhance pandemic vaccine regulatory preparedness across South-East Asia and the Eastern Mediterranean. Regulators from 10 countries took part in sessions on reliance strategies, safety monitoring and roadmap development. A simulation exercise addressed challenges across the vaccine life cycle - from authorization to surveillance - reinforcing national readiness and complementing WHO Academy training on pandemic response.
Photo: WHO
Facilitated Product Introduction
The WHO Facilitated Product Introduction team recently led key activities to strengthen regulatory reliance. A regional workshop on the WHO Collaborative Registration Procedure (CRP) was held in San Salvador, El Salvador with participation from 10 national regulatory authorities, regional bodies and stringent regulatory authorities. The workshop highlighted CRP’s value in verifying product sameness and strengthening reliance mechanisms. Honduras joined three CRP streams, and interest is growing across the Americas region.
Photo: WHO
Laboratory Networks and Services
The WHO Laboratory Networks and Services team has published the report from the WHO Global Network of National Quality Control Laboratories for Pharmaceuticals (WHO-GNP) Annual Meeting. The event marked the official launch of WHO-GNP and featured discussions on harmonization and best practices in quality control, along with training on measurement uncertainty and risk management. Participants reaffirmed their commitment to collaboration and continuous improvement in quality control. The full report is available on the WHO website for reference and further dissemination.
Photo: WHO
Pharmacovigilance
WHO is alerting health professionals to the risk of non-arteritic anterior ischemic optic neuropathy (NAION) linked to semaglutide medicines (Ozempic®, Rybelsus®, Wegovy®). Patients experiencing sudden or worsening vision loss should seek immediate medical advice. If NAION is confirmed, semaglutide treatment should be discontinued.
The twenty-first meeting of the Advisory Committee on Safety of Medicinal Products was held virtually and global safety recommendations are available. WHO also co-hosted a webinar with Germany’s Paul-Ehrlich-Institut to support the Gambian Medicines Control Agency in assessing Risk Management Plans. The Agency is considering adoption of WHO’s RMP Assessment Tools, currently under peer review. WHO also continues to support countries in transitioning from paper-based to electronic reporting of Adverse Events Following Immunization through VigiMobile. As of June 2025, VigiMobile is in use in nine countries.
Photo: WHO
Incidents and Substandard / Falsified Medical Products
WHO is seeking public feedback on a draft Target Product Profile for screening devices to detect diethylene glycol and ethylene glycol contamination in liquid medicines. This follows multiple fatal incidents involving contaminated cough and paracetamol syrups. Current detection methods, such as gas chromatography, are costly and often unavailable in low- and middle-income countries – where most contaminated products have been identified – highlighting the urgent need for affordable, portable screening tools for inspectors. Comments are welcome from industry, product developers, researchers, implementers and health workers. Feedback should be submitted using the provided form to rapidalert@who.int by Friday, 8 August 2025.
Photo: WHO / Khaled Mostafa
Cross-cutting initiatives
Knowledge Management
Boost your regulatory expertise – anytime, anywhere. Most RPQ e-learnings are now centralized on the WHO Academy platform, offering self-paced courses to strengthen knowledge across key regulatory topics. Courses include:
• Vaccine safety basics: EN, ES, FR, RU
• Recognizing and managing anaphylaxis: EN
• Communication-vaccine safety basics: CN
• Good reliance practices: EN, ES, FR
• Global Benchmarking Tool for assessors: EN, SP, FR
• Regulatory preparedness to authorize the use of pandemic vaccines in importing countries: EN
• Ethics and review of interventional clinical trials: EN
• Basic Fundamental of in vitro diagnostics medical devices regulation – A global approach: EN
Photo: WHO Knowledge Management
Upcoming events (organized by the RPQ Department)
Online Training on Method Validation and Verification (English), 20 & 27 August 2025
Online Training on Method Validation and Verification (French), September 2025 (date TBD)
Online Training on Risk Management, Q4 2025 (date TBD)
Online Training on Uncertainty of Measurement, Q4 2025 (date TBD)
Online Training on Data Integrity, Q4 2025 (date TBD)
Online Training on Validation of Computerized Systems, Q4 2025 (date TBD)
