WHO prequalification guide for checking health product lists
WHO prequalification supports procurement, not national authorization. Find official product lists and check medicines, APIs, vaccines and diagnostics.
WHO prequalification assesses and lists eligible health products against applicable quality, safety, efficacy and performance standards for international procurement. It does not replace national marketing authorization. WHO's fact sheet explains its procurement role. To check a medicine, API, vaccine or diagnostic, use the relevant live WHO list and match the exact product record. A manufacturer's name alone is not enough. WHO's medicines-list conditions state that inclusion does not imply WHO approval.
What the WHO prequalification programme is for
WHO PQ supports procurement by UN agencies, governments and partners. Products that meet its requirements are listed and become eligible for procurement. That eligibility does not guarantee a purchase. Nor is every health product eligible for assessment: applicants must check the scope of the relevant programme. WHO explains the purpose and eligibility limits.
For regulatory and procurement teams, two checks remain separate: the WHO listing and the national registration position. WHO's Collaborative Registration Procedure can help with national registration of prequalified products. It does not turn PQ into a global marketing authorization or remove the separate registration process. WHO describes that relationship in its fact sheet.
Where to find the WHO prequalification product lists
Start with the product category. These four official destinations cover finished medicines, active pharmaceutical ingredients, vaccines and in vitro diagnostics. They are not an exhaustive directory of every WHO PQ stream.
| Product category | Official WHO list | Fields to compare |
|---|---|---|
| Finished pharmaceutical products, or FPPs | Prequalified finished pharmaceutical products | WHO reference number, applicant, ingredient name, dosage form, strength and basis of listing |
| Active pharmaceutical ingredients, or APIs | Prequalified active pharmaceutical ingredients | WHO product ID, international nonproprietary name (INN), applicant, grade and prequalification date |
| Vaccines | Prequalified vaccines | Vaccine type, commercial name, manufacturer, presentation, doses and responsible national regulatory authority |
| In vitro diagnostics, or IVDs | Prequalified diagnostics gateway | Follow “List of prequalified in vitro diagnostics products”; compare product code, WHO product ID, regulatory version and manufacturer |
The medicines table has a detail that is easy to miss. Its “basis of listing” distinguishes “Prequalification - Full,” “Prequalification - Abridged” and “Alternative Listing.” A row in that table does not, by itself, establish that WHO performed a full PQ assessment. Read the listing basis before describing a product's status. Check the FPP table.
An API listing also has a narrower meaning than a finished-medicine listing. It identifies an API source acceptable in principle for manufacturing FPPs for UN procurement. It does not automatically make a finished medicine prequalified. The FPP manufacturer remains responsible for the API's suitability for its formulation. WHO explains the distinction between its medicines lists.
How to check whether a product is prequalified
Use the live record when making a procurement decision. An old certificate or saved search result cannot establish current status: WHO can suspend or remove medicines, and diagnostics can be suspended or delisted. See the medicines-list conditions and diagnostics list gateway.
- Open the correct product list from the table above. Search by the ingredient or product name, then compare the reference number or product ID. Match the applicant or manufacturer too. Use the fields for that category, rather than expecting every list to display the same information.
- Match the formulation or presentation. For a finished medicine, compare strength and dosage form. For a vaccine, compare presentation and doses. For a diagnostic, check the product code and regulatory version. A similar name is not a complete match. Use the relevant FPP, vaccine or IVD record.
- Check the detailed record and manufacturing sites. WHO expressly tells medicine purchasers to ensure that supplied products come from listed sites. Do not treat one product listing as approval of a company's whole portfolio or every factory. Read WHO's medicines-list conditions.
- Read the listing basis and conditions. For abridged medicines assessments, storage conditions or shelf life can differ from those accepted by the reference authority. WHO directs readers to Part 1 of the WHO Public Assessment Report, or WHOPAR. Check the listing conditions.
- Recheck status before the procurement decision. WHO cautions that it cannot guarantee continuing compliance of listed medicines and sites. Ongoing oversight includes changes to products, requalification, reinspection and quality monitoring. WHO describes the conditions and post-listing procedures.
Absence needs care too. An unlisted medicine is not necessarily unsafe. WHO notes that products outside its medicines list might meet the standards if assessed. The list conditions explain this limit.
How the WHO prequalification process works
There is no single assessment sequence for every product category. Applicants should use their stream's current procedures rather than copy a checklist from another programme.
Medicines and APIs
The medicines overview starts with eligibility under the invitation for expressions of interest. Applicants submit an application for screening. WHO then assesses the product dossier or API master file and checks relevant manufacturing or clinical-testing-site compliance. Products are listed when they meet the requirements. Eligible applications can follow an abridged pathway rather than a full assessment. WHO publishes the FPP and API procedures.
Medicines PQ activities also include quality-control testing. Compliance checks do not always require a new WHO on-site visit: Inspection Services can use inspection outputs from national authorities operating to equivalent standards and stringency. See the medicines programme and Inspection Services.
Vaccines
Vaccine PQ includes a pre-submission meeting and letter of intention, followed by dossier submission and screening. The procedure covers scientific assessment and verification of good manufacturing practice (GMP). It also includes independent initial testing of vaccine samples and manufacturing-site inspection before listing when requirements are met. Use the vaccine procedures for the application route, rather than the medicines instructions.
Diagnostics and the 2026 procedure
WHO's IVD overview describes a new assessment procedure starting in 2026. Performance evaluation becomes a separate procedure, rather than an internal PQ assessment stage. Applicants should check the current instructions for their application instead of assuming every pending dossier follows the new sequence. The main PQ activities listed are dossier assessment, labelling review and manufacturing-site inspection. Performance evaluation is a prerequisite for manufacturers of certain IVDs seeking PQ, not an identical requirement for every diagnostic. Check the current IVD overview.
Common questions about WHO PQ
Does “WHO approval” mean prequalification?
Do not use those terms interchangeably. WHO's medicines-list conditions reserve product and manufacturing-site approval to national authorities. If someone requests proof of “WHO approval,” clarify whether they need a PQ listing or national authorization. WHO states the limit of list inclusion.
Is Emergency Use Listing the same as PQ?
No. Emergency Use Listing, or EUL, is WHO's risk-based procedure for assessing and listing unlicensed products during public-health emergencies. Its criteria include a commitment to complete development and apply for PQ once licensed. An EUL entry does not establish a separate PQ status. WHO explains EUL.
Does authorization by a WHO-listed authority make a product prequalified?
No. WHO-listed authority, or WLA, designates a regulatory authority and recognizes its advanced performance. It is not a product or manufacturer PQ designation. Authorization by a WLA does not automatically confer WHO product prequalification. WHO describes the WLA framework.
See the RegAffairs AI answer on WHO prequalification. Check the live WHO record for the exact product and supplied manufacturing site before making a procurement decision, as described in the medicines-list conditions.