World Health Organization Prequalification Programme

World Health Organization Prequalification Programme
Name	World Health Organization Prequalification Programme
Formation	2001
Type	Program
Headquarters	Geneva, Switzerland
Parent organization	World Health Organization
Region served	Global

Contents

World Health Organization Prequalification Programme is an international initiative administered by World Health Organization to assess the quality, safety, and efficacy of priority health products for use by United Nations agencies, United Nations Children's Fund, Global Fund to Fight AIDS, Tuberculosis and Malaria, and national procurement bodies. The Programme works alongside regulatory authorities such as European Medicines Agency, Food and Drug Administration (United States), Medicines and Healthcare products Regulatory Agency, and regional bodies including African Union-linked institutions to enable access to antiretroviral therapy, antimalarial drugs, and essential diagnostics. It operates at the nexus of global procurement frameworks, humanitarian agencies like United Nations High Commissioner for Refugees and international initiatives such as Gavi, the Vaccine Alliance and Stop TB Partnership.

History and background

The initiative began in response to public health needs highlighted by outbreaks and treatment gaps during the late 20th century, engaging stakeholders from World Health Assembly deliberations, Bill & Melinda Gates Foundation, and donor states including United Kingdom, United States, and Switzerland. Early activities drew on regulatory experience from European Directorate for the Quality of Medicines & HealthCare, technical standards from International Organization for Standardization, and procurement models used by Pan American Health Organization. Over time it expanded through collaborations with United Nations Development Programme, World Bank, and bilateral agencies such as United States Agency for International Development to cover medicines, vaccines, diagnostics, and vector control products. Key milestones were alignment with the World Health Assembly resolutions, integration with Global Drug Facility mechanisms, and formal recognition in procurement lists of multilateral partners.

The Programme targets product classes prioritized by World Health Organization public health guidance, including antiretroviral therapy, tuberculosis (TB) treatment, malaria treatment, contraceptives endorsed by United Nations Population Fund, and in vitro diagnostics for diseases like HIV/AIDS, hepatitis C, and COVID-19 pandemic testing. Objectives include assuring product quality for procurement by entities such as United Nations Children's Fund, reducing duplication of regulatory assessment for manufacturers interacting with agencies like European Medicines Agency and Food and Drug Administration (United States), and informing national regulatory authorities such as Health Canada and Therapeutic Goods Administration through assessment reports. The scope encompasses prequalification of medicines, vaccines, in vitro diagnostics, and vector control products used in programs led by actors such as Global Fund to Fight AIDS, Tuberculosis and Malaria, Gavi, the Vaccine Alliance, and United Nations Relief and Works Agency for Palestine Refugees in the Near East.

Manufacturers submit dossiers comparable to submissions to national regulators like Medicines and Healthcare products Regulatory Agency or European Medicines Agency, and the Programme evaluates chemistry, manufacturing and controls, clinical data, and quality management systems with reference to standards from International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and World Health Assembly policy. Assessments include on-site inspections of facilities, laboratory testing aligned with United States Pharmacopeia and European Pharmacopoeia, and post-market surveillance coordinated with national regulators such as South African Health Products Regulatory Authority and regional networks including African Vaccine Regulatory Forum. Criteria emphasize bioequivalence, stability, good manufacturing practice, and evidence of clinical effectiveness derived from trials registered at ClinicalTrials.gov or submitted to regulatory bodies like European Medicines Agency. Successful products are listed for procurement by institutions like United Nations Children's Fund and Global Fund to Fight AIDS, Tuberculosis and Malaria; conditional pathways have been used during emergencies such as the Ebola virus epidemic in West Africa and COVID-19 pandemic.

Governance includes oversight by World Health Organization technical units and advisory committees with experts drawn from World Health Assembly member states, academic centers such as Johns Hopkins University, and regulatory authorities like Medicines and Healthcare products Regulatory Agency. Funding sources combine assessed contributions from World Health Organization budgets, earmarked grants from philanthropic organizations such as Bill & Melinda Gates Foundation, and procurement-linked fees from manufacturers and partners like Gavi, the Vaccine Alliance and Global Fund to Fight AIDS, Tuberculosis and Malaria. Partnerships extend to laboratories such as Centers for Disease Control and Prevention, standard bodies like International Organization for Standardization, and procurement agencies including United Nations Office for Project Services. The Programme coordinates technical cooperation with regional regulatory harmonization initiatives such as African Medicines Regulatory Harmonization.

The Programme has enabled wider international procurement of WHO-listed products by agencies including United Nations Children's Fund and Global Fund to Fight AIDS, Tuberculosis and Malaria, increased market access for manufacturers from countries such as India and China, and supported scale-up of interventions during emergencies like the Ebola virus epidemic in West Africa and COVID-19 pandemic. It has influenced national regulatory strengthening seen in reforms in countries such as Nigeria and Ethiopia, facilitated access to treatments for HIV/AIDS, tuberculosis, and malaria, and contributed to global surveillance networks coordinated with World Health Organization and Centers for Disease Control and Prevention. Procurement lists derived from prequalification have guided purchasing by United Nations agencies, non-governmental organizations such as Médecins Sans Frontières, and bilateral programs run by United States Agency for International Development.

Critiques include concerns about reliance on centralized lists by agencies like United Nations Children's Fund which may affect market dynamics for manufacturers in regions such as Latin America and Sub-Saharan Africa, potential delays relative to assessments by regulators like European Medicines Agency or Food and Drug Administration (United States), and the need for sustained funding from donors including Bill & Melinda Gates Foundation and member states. Stakeholders such as Médecins Sans Frontières and national regulatory authorities have called for greater transparency in dossier assessments, faster conditional pathways during health emergencies like the COVID-19 pandemic, and enhanced support for regulatory capacity building in networks such as African Medicines Regulatory Harmonization. Operational challenges include balancing rigorous inspection standards with timely access during outbreaks such as Ebola virus epidemic in West Africa and coordinating post-market surveillance with entities like Centers for Disease Control and Prevention.