WHO prequalification and donor-funded tenders

Many medicines for HIV, tuberculosis, malaria and other public health programmes in low and middle income countries are paid for with donor money or bought through pooled procurement. Those buyers do not rely on price and paperwork alone. They ask whether the specific product has passed a quality assessment they recognise, usually WHO prequalification or approval by a trusted regulator. A medicine that fails that test cannot be bought with the grant, however well it is made.

This guide explains how WHO prequalification works, what the Global Fund quality assurance policy requires, how other pooled buyers approach quality, and what a supplier in India or a tender team should check before responding.

Who buys with donor or pooled funds

Several buyers dominate this market, and each publishes its own rules.

The PAHO Strategic Fund describes itself as a regional mechanism for pooled procurement of medicines on the WHO Model List of Essential Medicines. It serves ministries of health and public institutions in member countries that sign an agreement and prepay PAHO. UNICEF's quality assurance page says it tests supplier samples, sends complex products to specialised laboratories and inspects goods before delivery and on receipt, checking specifications, labelling, documentation and shelf life.

How WHO prequalification works

WHO medicines prequalification began in 2001 after problems with the quality of medicines and their supply. Today the programme also covers vaccines, in vitro diagnostics, immunization devices and vector control products, and its about page says almost 1,500 products have been prequalified across its streams.

For medicines, WHO assesses finished pharmaceutical products, active ingredients and quality control laboratories. It publishes invitations, called expressions of interest, that list which medicines are eligible for assessment. A manufacturer submits a dossier, WHO assesses it and inspects the sites, and the product joins the list once it passes. Abridged routes exist for products already approved by a regulator applying stringent standards.

Two points matter for anyone responding to a tender:

• Prequalification is product and site specific. It covers one manufacturer's product made at named sites. The same medicine from another factory, or relabelled by another company without being listed, is not covered.
• It is not a national licence. Countries still decide whether a product may be used. WHO runs a collaborative registration procedure that helps national regulators register prequalified products faster, since registration can otherwise take two to three years in the worst cases.

A WHO-GMP certificate is a separate document. It is issued by a national regulator to confirm that a manufacturing site follows WHO good manufacturing practice guidelines. It does not mean WHO has assessed the product, so it does not meet a prequalification clause.

The Global Fund quality assurance policy

The Global Fund's current policy dates from November 2023. For antiretrovirals, tuberculosis medicines and malaria medicines, principal recipients may only choose finished products that meet one of four routes:

1. Prequalified by the WHO Prequalification Programme.
2. Authorised by a stringent regulatory authority. Under an interim WHO definition endorsed in June 2018, these are authorities that were ICH members or observers before 23 October 2015.
3. Authorised by a WHO-listed authority. The WHO-listed authority framework is replacing the procurement-oriented stringent regulator concept, and the first listings were announced on 31 October 2023.
4. Recommended by the Expert Review Panel for time-limited use.

All other finished products bought with grants must comply with the national regulations and relevant quality standards of the country where they are used.

The Expert Review Panel

The Expert Review Panel is hosted by WHO. It reviews the risks and benefits of products that are not yet prequalified or approved by a stringent regulator, and it is used when only one or no assured product is available. The Global Fund then issues a no-objection letter for a limited period, and its independent laboratory tests the product before shipment. Manufacturers submit products after an invitation, in two regular rounds a year or in ad hoc rounds. For medicines, the submission includes a letter showing that WHO prequalification or a stringent regulator has accepted the dossier for assessment, a GMP certificate and the interagency product questionnaire.

The route is a bridge, not a destination. The Global Drug Facility's 2010 policy, for example, limited a panel recommendation to 12 months and expected the product to reach prequalification or stringent approval within that period.

What this means for a supplier in India

Whatever the country of manufacture, eligibility always sits with the manufacturer's product. An exporter or distributor can supply an eligible product and its documents. It cannot make an ineligible product eligible, and it should not describe a product as prequalified unless the listing, the site and the presentation all match.

Before quoting, a tender team or exporter should check:

• the exact product, strength, pack and manufacturing site against the WHO prequalification list, the stringent or WHO-listed regulator approval, or the panel's current recommendations
• whether the product is registered, or can be imported under a waiver, in the recipient country, using the relevant country guide such as Nigeria, Kenya or Tanzania
• the remaining shelf life the tender requires on delivery, as covered in shelf-life requirements in medicine supply
• whether pre-shipment inspection or testing applies, since the Global Fund tests panel-recommended products before shipment

National rules often mirror these donor standards. Brazil's RDC 203/2017, described in the Brazil import guide, lets the Ministry of Health import unregistered products for public programmes if they are WHO-prequalified or registered in an ICH member country. Kazakhstan's import rules allow unregistered medicines supplied by UN bodies or from WHO-prequalified sources to its single distributor under an import conclusion, as set out in the Kazakhstan import guide.

Responding to a donor-funded tender

1. Read the quality clause and note which policy it cites, for example the Global Fund policy or the buyer's own technical requirements.
2. Match each line to an eligible product and record its prequalification reference, regulator approval or panel recommendation and expiry.
3. Confirm national registration or the waiver route in the recipient country.
4. Collect the documents: eligibility evidence, GMP certificate, certificate of pharmaceutical product, batch certificates of analysis and any product questionnaire.
5. Agree the Incoterm, delivery point and temperature conditions. The Incoterms guide explains the common choices.
6. Plan lead time for production, pre-shipment inspection, export and transit with the lead-time estimator.
7. Ship with complete batch records and keep proof of delivery and receipt inspection results.

UN organisations publish opportunities on the UN Global Marketplace, where a supplier registers once for access to up to 32 organisations. UNICEF says all its supplier applications go through it and that registration is free.

Common mistakes

• Treating WHO-GMP as prequalification. The two documents answer different questions.
• Quoting a different site or pack. Eligibility can depend on the exact presentation and manufacturing site.
• Ignoring expiry of a panel recommendation. Time-limited clearance can lapse before delivery.
• Forgetting national registration. Donor eligibility does not replace the recipient country's own rules.
• Underestimating shelf life. Receipt inspections check it, and short-dated stock can be refused.