WHO Regulation and Prequalification Update
WHO Regulation
and Prequalification
UPDATE
Message from the RPQ Director
As we continue to navigate complex global health challenges, the importance of ensuring safe, effective, and quality assured health products has never been more critical. The WHO Regulation and Prequalification (RPQ) team remains committed to our role in safeguarding global public health by implementing international standards and supporting countries in the regulation and prequalification of medicines, vaccines, diagnostics, and other health products. Together, we are making strides toward ensuring that everyone, everywhere, has access to life-saving health products they can trust.
Today we start a renewed monthly departmental update, now in all six WHO official languages. We will also publish special issues, the first to appear soon dedicated to the 19th ICDRA, recently held in New Delhi. As we face specific challenges in response to outbreaks, epidemics and pandemic events, the most recent being mpox and Marburg in East and Central Africa, we continuously face the challenges of providing access to adequately quality assured, safe and efficacious medical products for universal health coverage. To all who support this work, we extend our deepest appreciation and recognition for the demanding yet essential efforts you perform daily.
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
Inspection Services plays a key role in supporting the prequalification of priority health products by ensuring their quality, safety and efficacy through initial and follow-up inspections. Collaborating with national regulatory agencies and partners, Inspection Services works to strengthen regulatory capacity and promote harmonized standards in product manufacturing and monitoring. The programme has recently reactivated its rotational inspectors, welcoming candidates from Rwanda and Indonesia for hands-on training. Recent onsite inspections include various sites in China, India, Indonesia, Senegal, Thailand and Vietnam.
In Vitro Diagnostics
WHO invited manufacturers to submit in vitro diagnostics (IVDs) for Monkeypox virus nucleic detection for review through the Emergency Use Listing (EUL) procedure. Two IVDs are now listed. In addition, the PQT/IVD launched two consultations: one to gather public feedback on a proposed new process for IVD prequalification and another inviting input on new guidance for reportable changes to prequalified and EUL-listed IVDs.
Medicines
As of 29 September 2024, the number of newly prequalified medicines has increased to 35. PQT/MED recently held two annual manufacturer workshops, bringing together nearly 300 industry participants. In September, the 141st Assessment Session convened, with around 70 experts from Africa, South America and Asia. To address the ongoing rifampicin shortage, PQT/MED is prioritizing the review and approval of new sources, while maintaining regular updates to key stakeholders such as the Global Drug Facility and the Global Fund to Fight AIDS, Tuberculosis and Malaria.
Note: The English text was updated on 1 November 2024.
Vaccines and Immunization Devices
WHO has prequalified several new vaccines: Fluzone, a trivalent influenza vaccine, a second nOPV2 polio vaccine to support global eradication, the first mpox vaccine (Imvanex) for ages 12+, and ZyVac, a Typhoid Vi Conjugate Vaccine for ages 6 months to 65 years. These approvals expand access and support global health initiatives against influenza, polio, mpox and typhoid.
Note: The English text was updated on 1 November 2024.
Vector Control Products
With rising demand for insecticide-treated mosquito nets containing two active ingredients outpacing supply from a limited number of manufacturers, PQT/VCP responded swiftly to the needs of Member States and procurement partners by prioritizing the assessment of these essential products. Given their multi-year lifespan, aligning prequalification, procurement and distribution is crucial. In response, PQT/VCP prequalified the Yorkool G5 insecticide-treated mosquito net in just four months – well ahead of the usual 12-month timeline – demonstrating a strong commitment to supporting global health efforts.
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
India's vaccine regulatory system has achieved Maturity Level 3, during the re-benchmarking by WHO, meeting the requirements established under the WHO Global Benchmarking Tool (GBT) revision VI. This highlights India’s continuous improvement in regulatory capacity, ensuring high-quality vaccines for global supply. The collaboration between WHO and India’s Central Drugs Standard Control Organization underscores India's commitment to enhancing global health and vaccine safety standards.
Regulatory Convergence and Networks
To enhance global regulatory capacity for overseeing medical products, WHO promotes international cooperation among regulatory authorities through various approaches, including convergence, harmonization, information-sharing, work-sharing, reliance and recognition. The Regulatory Convergence and Network team plays a key role in supporting Member States by facilitating efforts related to regulatory convergence, fostering regional and international regulatory networks and advancing harmonization initiatives. This collaborative approach strengthens the global framework for ensuring the safety and quality of medical products.
Facilitated Product Introduction
Ghana's Food and Drugs Authority (FDA) has successfully registered the first vector control product through the WHO Collaborative Registration Procedure (CRP), completing the process for a long-acting insecticide-treated mosquito net in just 28 working days. Launched in January 2024, the CRP streamlines product registration across six countries by leveraging WHO prequalification assessments. This approach accelerates access to life-saving vector control products, with broader implementation expected next year, benefiting more countries and improving regulatory efficiency for urgent public health needs.
Laboratory Networks and Services
The WHO Global Network of National Quality Control Laboratories for Pharmaceuticals (WHO-GNP) was launched in October 2024, aiming to strengthen collaboration, technical capacity and best practices among member labs. The network promotes harmonization, reliance and efficient use of resources in pharmaceutical quality control. It also supports laboratories in achieving WHO Prequalification for international recognition. With participation from 43 countries and over 150 attendees, WHO-GNP is set to foster global standards and improve the quality and safety of medicines worldwide. The first meeting brought together 50 onsite participants from 32 countries across all six WHO regions, along with over 110 online attendees.
Pharmacovigilance
WHO launched the new Vaccine Safety Net (VSN) portal, a global network of websites offering reliable, evidence-based information on vaccine safety. The VSN ensures accurate, up-to-date information is accessible worldwide to help people make informed vaccination decisions. WHO also welcomes two new members to the network: the Ministry of Health website from Trinidad and Tobago and the CHLAEP website from Uruguay.
Incidents and Substandard / Falsified Medical Products
WHO has issued its second Medical Product Alert of 2024 regarding falsified Propylene Glycol (USP/EP), a raw material used in pharmaceutical manufacturing. These falsified products are suspected to be linked to contamination in oral syrups, causing acute kidney injuries in children in at least four countries. WHO is actively monitoring the issue and collaborating with stakeholders to identify weaknesses in the global supply chain. A detailed report on these vulnerabilities is expected in 2025.
Cross-cutting initiatives
Knowledge Management
To strengthen regulatory workforce capacity, the department has developed several trainings on regulatory functions and health products. Training methods include e-learning, instructor-led sessions and on-the-job training. The department, in alignment with the WHO Academy strategy, is also refining its training efforts to meet the growing demand from Member States for developing, strengthening and sustaining regulatory workforce capacities and capabilities.
Quality Management Systems
Quality Management has developed a Quality Management System (QMS) Roadmap, outlining key milestones and timelines for enhancing its QMS through the end of 2025. The roadmap focuses on the development and implementation of both cross-cutting and team-specific standard operating procedures to continuously improve service quality. A one-day retreat was held to reflect on these goals and discuss the roadmap's implementation.
Upcoming events (organized by the RPQ Department)
12th Annual Meeting on the Collaborative Registration Procedure, Jakarta, Indonesia, 12-14 November 2024
6th meeting of the WHO National Control Laboratories Network for Biologicals, Cairo, Egypt, 26-28 November 2024
Joint WHO-UNICEF-UNFPA Meeting with Manufacturers and Suppliers, Copenhagen, Denmark, 2-6 December 2024
Workshop for Asian manufacturers of IVDs: from quality assurance to procurement, Jakarta, Indonesia, 20-23 January 2025
