WHO PQS
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| WHO PQS | |
|---|---|
| Name | WHO PQS |
| Formation | 2001 |
| Headquarters | Geneva |
| Parent organization | World Health Organization |
| Region served | Global |
WHO PQS
The WHO Prequalification of In Vitro Diagnostics, Medical Devices and Medicines (PQS) is a technical evaluation and quality assurance mechanism operated by the World Health Organization based in Geneva. It provides a standardized pathway for assessment, listing, and monitoring of pharmaceuticals, medical devices, diagnostics, and related health products deployed in global health programmes supported by multilateral purchasers and national regulators. PQS aligns with international standards used by agencies such as UNICEF, Global Fund, and Gavi, the Vaccine Alliance to facilitate procurement, funding, and emergency response.
Overview
PQS functions as a centralized quality mark that signals conformance with standards recognized by World Health Organization member states and international procurement bodies. The programme evaluates manufacturers, dossiers, and product performance to determine acceptability for supply to health programmes coordinated by entities including United Nations Relief and Works Agency for Palestine Refugees in the Near East, UNFPA, and the Joint United Nations Programme on HIV/AIDS. PQS complements regulatory pathways such as those maintained by the European Medicines Agency, the U.S. Food and Drug Administration, and stringent regulatory authorities of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use members.
History and Development
PQS emerged in the early 2000s as part of broader post-1990s reforms to global health procurement and regulatory convergence following initiatives like the Batch Release reforms and harmonization efforts led by the World Health Organization. The programme evolved through collaboration with stakeholders including Médecins Sans Frontières, the Bill & Melinda Gates Foundation, and national regulatory authorities such as the Medicines and Healthcare products Regulatory Agency (UK) and the Central Drugs Standard Control Organization (India). Major milestones include expansion from essential medicines to diagnostics and devices, integration with emergency use listing processes seen during the Ebola virus epidemic in West Africa and the COVID-19 pandemic, and technical guideline updates reflecting standards from the International Organization for Standardization and the World Customs Organization.
Scope and Objectives
PQS covers categories including antiretrovirals, antimalarials, vaccines, diagnostics for HIV/AIDS, tuberculosis, and malaria, and devices such as oxygen concentrators and cold chain equipment used in immunization programmes like those run by UNICEF and Gavi, the Vaccine Alliance. Objectives include ensuring product safety, efficacy, and quality for procurement by multilateral buyers; harmonizing expectations for manufacturers supplying low- and middle-income countries; and supporting national regulatory authorities in capacity building alongside initiatives like the African Vaccine Regulatory Forum. PQS aims to reduce duplication of assessment by linking to dossiers reviewed by the European Medicines Agency and relying on approvals from stringent regulatory authorities where appropriate.
Prequalification Procedures
The PQS process typically involves dossier submission, technical review, site inspection of manufacturing facilities, and post-listing surveillance. Dossier assessment draws upon standards from the International Pharmacopoeia and relies on testing at WHO-designated laboratories and collaborating centres such as Institut Pasteur. Inspections reference benchmarks used by agencies like the U.S. Food and Drug Administration and the Medicines and Healthcare products Regulatory Agency. For emergencies, PQS coordinates with the WHO Emergency Use Listing mechanism, which was instrumental during the 2014–2016 Ebola virus epidemic in West Africa and the 2019–20 coronavirus pandemic. Conditional listings and time-limited authorizations are used when expedited access is necessary.
Impact and Criticism
PQS has influenced global procurement markets by streamlining access to quality-assured products for programmes financed by the Global Fund to Fight AIDS, Tuberculosis and Malaria, UNICEF, and bilateral donors like United States Agency for International Development. Critics, including representatives from Médecins Sans Frontières and some industry groups, have argued that PQS criteria and timelines can favor larger manufacturers in European Union and United States markets, potentially limiting competition from producers in regions such as South-East Asia and Africa. Discussions in forums such as the World Health Assembly focus on balancing rapid access in crises with rigorous quality assurance and on enhancing transparency and capacity building for national regulators like those in the African Union member states.
Governance and Partnerships
PQS operates within the governance framework of the World Health Organization and engages with partners including UNICEF, Global Fund, Gavi, the Vaccine Alliance, the Bill & Melinda Gates Foundation, and national regulatory authorities such as the Indian Council of Medical Research. It relies on technical advisory groups, collaborating centres like Institut Pasteur, and harmonization initiatives including the International Pharmaceutical Regulators Programme. Procurement agencies and donors use PQS listings as eligibility criteria, while academic partners such as London School of Hygiene & Tropical Medicine and Johns Hopkins Bloomberg School of Public Health contribute research and policy analysis.
Implementation and Global Reach
PQS-listed products are used across programmes in regions covered by the World Health Organization regional offices, including the Regional Office for Africa, the Regional Office for South-East Asia, and the Regional Office for the Americas. The listing facilitates procurement by agencies such as UNICEF, the Global Fund, and national ministries of health in countries like Kenya, India, Brazil, and South Africa. During public health emergencies such as the COVID-19 pandemic and the Ebola virus epidemic in West Africa, PQS coordinated with the WHO Health Emergencies Programme to expedite access to diagnostics and devices while maintaining oversight through post-market surveillance and capacity-strengthening initiatives for regulatory authorities in low- and middle-income countries.