WHO Prequalification Program
The World Health Organization Prequalification Programme ensures that medicines used by international procurement agencies meet acceptable standards of quality, safety, and efficacy for priority diseases in low- and middle-income countries.
270 Days
Target Assessment
90+
Countries Served
eCTD/CTD
Accepted Formats
WHO GMP
Inspection Required
Programme Overview
The WHO Prequalification Programme (WHO-PQ) was established in 2001 to ensure that medicines procured by international agencies — including UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and PEPFAR — meet acceptable standards of quality, safety, and efficacy. The programme operates as a service provided by WHO to facilitate access to quality-assured priority medicines in resource-limited settings where national regulatory capacity may be insufficient to independently verify product quality.
WHO-PQ evaluates and prequalifies Finished Pharmaceutical Products (FPPs) and Active Pharmaceutical Ingredients (APIs) through a rigorous assessment process that includes scientific dossier review, GMP inspection of manufacturing sites, and ongoing quality surveillance. Prequalification status is not a one-time achievement — products are subject to regular requalification, annual reporting requirements, and post-marketing surveillance to maintain their prequalified status.
Submission Format
WHO accepts submissions in both eCTD and CTD formats. While eCTD is preferred and encouraged for new submissions, the traditional paper-based CTD format remains acceptable. Applicants are strongly encouraged to transition to eCTD submissions to facilitate more efficient assessment and lifecycle management.
Priority Disease Areas
WHO-PQ focuses on medicines for three major infectious diseases that disproportionately affect populations in low- and middle-income countries. These priority areas align with global health initiatives and procurement programmes.
HIV/AIDS
Prequalification of antiretroviral (ARV) medicines including first-line, second-line, and third-line treatment regimens. Covers single-entity and fixed-dose combination products for adult and paediatric populations. WHO-PQ ARVs are critical for PEPFAR and Global Fund procurement.
Key Prequalified Products
Tenofovir, Lamivudine, Dolutegravir, Efavirenz, Lopinavir/Ritonavir, Abacavir, and numerous FDCs
Tuberculosis
Prequalification of anti-tuberculosis medicines for drug-susceptible and drug-resistant TB. Includes first-line agents (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol), second-line agents (Bedaquiline, Delamanid, Linezolid), and fixed-dose combinations for DOTS programmes.
Key Prequalified Products
Rifampicin/Isoniazid FDC, Bedaquiline, Delamanid, Pretomanid, Linezolid, RHZE combinations
Malaria
Prequalification of artemisinin-based combination therapies (ACTs) and other antimalarial medicines. Covers treatment of P. falciparum and P. vivax malaria, including paediatric formulations. WHO-PQ antimalarials are essential for national malaria control programmes and Global Fund procurement.
Key Prequalified Products
Artemether/Lumefantrine, Artesunate/Amodiaquine, Dihydroartemisinin/Piperaquine, Injectable Artesunate
FPP Prequalification Requirements
Finished Pharmaceutical Products (FPPs) submitted for WHO prequalification must meet stringent quality, safety, and efficacy standards. The following documentation is required for a complete prequalification dossier:
Quality Documentation (Module 3)
Complete chemistry, manufacturing, and controls data for the finished pharmaceutical product, including drug substance and drug product specifications, manufacturing process descriptions, batch analyses, stability data, and comparator dissolution profiles.
Bioequivalence Studies (Module 5)
Comparative bioavailability studies demonstrating bioequivalence to the WHO-designated comparator product. Studies must comply with WHO guidelines on registration requirements for multisource pharmaceutical products and must be conducted at WHO-prequalified or GLP-compliant bioanalytical laboratories.
Product Information
Summary of Product Characteristics (SmPC), patient information leaflet, and labelling in compliance with WHO requirements. Information must align with the approved comparator product labelling and include all relevant safety information.
GMP Compliance
Evidence of compliance with WHO Good Manufacturing Practice standards. Manufacturing sites must be inspected and found compliant by WHO or a stringent regulatory authority (SRA). The inspection report must be current (within the past 3 years).
Clinical Efficacy Data (if required)
For certain product categories, particularly fixed-dose combinations and novel formulations, WHO may require additional clinical evidence beyond bioequivalence to support prequalification.
API Prequalification Requirements
Active Pharmaceutical Ingredients (APIs) can be independently prequalified by WHO, providing a quality assurance framework for drug substance manufacturers. API prequalification is particularly important for ensuring supply chain integrity when FPP manufacturers source active ingredients from multiple suppliers across different countries.
Complete Master File documentation for the Active Pharmaceutical Ingredient
Drug substance characterisation including physicochemical properties, polymorphism, and particle size
Detailed manufacturing process description with critical process parameters and in-process controls
Impurity profile analysis including identified and unidentified impurities against ICH Q3A limits
Stability data under ICH conditions (long-term, accelerated, and stress testing)
Specifications and validated analytical methods for identity, assay, and impurity testing
Evidence of GMP compliance at the API manufacturing site (WHO or SRA inspection)
Procurement Agencies
UNICEF Supply Division
Procures medicines and health supplies for maternal, newborn, and child health programmes in over 150 countries. UNICEF mandates WHO prequalification status for all pharmaceutical products it procures.
The Global Fund
The Global Fund to Fight AIDS, Tuberculosis and Malaria requires that all pharmaceutical products purchased with its funds are either WHO-prequalified or approved by a stringent regulatory authority (SRA). This ensures quality and safety of medicines reaching patient populations.
PEPFAR (U.S. President's Emergency Plan)
The largest global initiative for combating HIV/AIDS. PEPFAR requires that ARV medicines procured through its programme hold either WHO-PQ status or US FDA tentative/full approval.
Unitaid & GAVI
International health financing organisations that rely on WHO prequalification as a benchmark for procurement eligibility. Their investments catalyse market access for quality-assured health products in low- and middle-income countries.
Key Reference Documents
WHO Technical Report Series (TRS)
Published WHO Expert Committee recommendations on specifications for pharmaceutical preparations
WHO Guidelines on Bioequivalence
Multisource (generic) pharmaceutical product registration requirements including BE study guidelines
WHO Prequalification: Medicines Assessment
Procedures and guidance for the assessment of medicines submitted for WHO prequalification
WHO GMP Guidelines (TRS 986, Annex 2)
Good Manufacturing Practice standards required for WHO prequalification of manufacturing sites
ICH CTD/eCTD Guidelines
WHO accepts submissions structured per the ICH Common Technical Document format
WHO Model List of Essential Medicines
Core list of medicines addressing priority health needs, many of which are eligible for prequalification
Reference Document
WHO Prequalification Technical Documentation
Technical guidance for medicines prequalification assessment and submission requirements
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