WHO Prequalification Explained
What is WHO prequalification?
WHO prequalification is the World Health Organization's assessment of medical products for quality, safety and efficacy. Products that pass go on WHO's prequalified lists, which procurement agencies and countries use to buy quality-assured products, mainly for low- and middle-income countries (WHO PQ portal; About medicines PQ).
What it covers WHO's portal lists these prequalification streams (WHO PQ portal):
- Medicines: finished pharmaceutical products (FPPs) and active pharmaceutical ingredients (APIs)
- Vaccines
- In vitro diagnostics (IVDs)
- Immunization devices
- Medical devices
- Vector control products
- Inspection services
WHO says it has "prequalified almost 1,500 products". It links a 25-year history of the vaccines programme covering 1987–2012, so that stream began in 1987 (About PQ).
How it works (medicines) WHO describes three core activities (About medicines PQ):
- "assessment of product dossiers (for finished pharmaceutical products (FPPs) or master files (for active pharmaceutical ingredients (APIs)".
- "inspection of manufacturing and clinical sites".
- "organization of quality control testing of products".
The standards are "based on the principles and practices agreed by the world's leading regulatory agencies and adopted by the WHO Expert Committee on Specification for Pharmaceutical Preparations."
Related pathways
- Abridged assessment: an API master file already accepted "by an authority applying stringent standards" can follow a shorter route (abridged procedure).
- Quality control labs: WHO also prequalifies quality control laboratories that do chemical and microbiological testing of medicines.
- Collaborative registration: this procedure helps a prequalified product get registered faster in national markets (collaborative procedure).
- Emergency use listing: the portal also lists this procedure for vaccines and diagnostics (WHO PQ portal).
Why it matters WHO says prequalification "has enabled a large donor-funded market size of approximately US$ 3.5 billion". It adds that prequalified IVDs, medicines and vaccines "are procured by national governments, as well as private-sector organizations within country" (About PQ). The pages I opened do not say whether taking part is voluntary.
Approach: I read WHO's official prequalification pages. I couldn't check our copy of WHO's prequalified medicines and WHO Listed Authority lists this time, so I have no specific product entries to show.
How can I check whether a product is prequalified?
To check whether a product is prequalified, search WHO's official prequalified-product list for its stream on the WHO Prequalification portal. A product counts as prequalified only if it is on the list. For medicines, the listing also has to match the specific manufacturing site. Each stream has its own list, and most can be filtered online and downloaded as a CSV file.
Where to look, by product type
| Stream | WHO list | What you can search or filter by | Entries shown when opened |
|---|---|---|---|
| Finished medicines (FPPs and biotherapeutics) | Prequalified FPPs | WHO reference number, INN/dosage form/strength, applicant, therapeutic area, product type, single or fixed-dose combination, basis of listing (full or abridged PQ vs alternative listing such as EMA Article 58, Health Canada, TGA, USFDA-PEPFAR), prequalification date range | 657 |
| APIs | Prequalified APIs | WHO product ID, INN, grade, therapeutic area, applicant, date of prequalification, Confirmation of Prequalification document date | 197 |
| QC laboratories | Prequalified QC labs | WHO region, country | 68 |
| Vaccines | Prequalified vaccines | Vaccine type, commercial name, manufacturer, responsible NRA, form, doses, route, presentation, preservative, diluent, shelf life, vaccine vial monitor (VVM) type | 286 |
| IVDs | Prequalified IVDs | Product name, manufacturer, IVD category. The table also shows product code, WHO product ID, regulatory version, year of prequalification | 125 |
| Vector control | Prequalified vector control products | Product type, applicant, active ingredient or synergist. The table shows the PQT/VC reference number and prequalification date | 98 |
| Immunization devices | IMD-PQS catalogue | Search-and-compare tool or browse by category; full catalogue downloadable as PDF or JSON. Each product has a unique IMD-PQS code in the form E0XX/XXX, which is never reassigned | not stated |
| Medical devices | Prequalified medical devices | A downloadable list file rather than an online search | not stated |
The counts are what each list page showed when I opened it.
How to confirm a match (medicines) WHO's notes on the medicines list set out these points:
- Manufacturing site: buyers must "ensure that only products from the manufacturing sites mentioned in this list are supplied to it." Matching the INN and the applicant is not enough; the site has to match too.
- Full details: "more information concerning the product(s) is displayed when the list ... is downloaded as an Excel spreadsheet."
- Reference labels: products prequalified through WHO's own assessment get WHO reference numbers. Products listed on the basis of FDA, EMA or Swissmedic approval carry those authorities' reference labels instead.
- Status can change: WHO "may suspend or remove products from the list." It also says it "cannot guarantee that the listed products and manufacturing sites will continue to meet the aforesaid standards." So check the live list, not an old printout.
- Not an endorsement: being listed "does not constitute an endorsement, or warranty of the fitness, by WHO of any product for a particular purpose."
For vaccines, WHO likewise says it "may suspend or remove a vaccine from the list" (vaccine list overview). To see the evidence behind a listing, use the public assessment reports (WHOPARs) and public inspection reports (WHOPIRs) on WHO's medicines reports page.
If you tell me a product name, INN or WHO reference number, I can look it up.
Approach: I tried our copy of WHO's prequalified medicines and WHO Listed Authority lists but couldn't check it this time, so this answer comes from WHO's official prequalification list pages, which I opened today.