Home - Prequalification: Invitations for Expressions of Interest

Invitations for Expressions of Interest (EOIs)

To quality control laboratories

To manufacturers of medicinal products

The World Health Organization operates the WHO Prequalification Programme on behalf of the United Nations.

 

The vision of the WHO Prequalification Programme is of a world in which good-quality medicines are available to all those who need them.  The Programme facilitates access to good-quality medicines through assessment of products and inspection of manufacturing facilities. Products that meet assessment criteria are added to the WHO List of Prequalified Medicinal Products.  UN agencies and others use the List to guide them in their procurement decisions. Manufacturers of prequalified products may therefore be invited by WHO Member States or UN agencies, or nongovernmental organizations, to submit tenders for supply of their prequalified product (preferably at a preferential price if supply will be to a developing country).

 

The first step in the prequalification process consists in the joint issuing, by the WHO Prequalification Programme, other UN agencies (UNAIDS and UNICEF) and UNITAID, of an Invitation for Expression of Interest (EOI). EOIs focus on products that have been identified by the respective WHO disease departments as vital to effective treatment and to expanding treatment programmes. Currently, this means products for treating HIV/AIDS, TB and malaria, and for reproductive health. Every product contained in an EOI is already included on the WHO Model List of Essential Medicines and/or in WHO treatment guidelines.

 

Each EOI invites manufacturers to submit a request for an evaluation of their product(s).  In applying for product evaluation, manufacturers are requested to submit a covering letter, product dossier, product sample and site master file to the WHO Prequalification Programme.

 

The Programme undertakes comprehensive evaluation of the quality, safety and efficacy of medicinal products, based on information submitted by the manufacturers, and inspection of the corresponding manufacturing sites.  Products submitted for prequalification are often multi-source generics.  In such cases, therapeutic equivalence with an innovator product is verified by performing a bioequivalence study.  Such studies are generally carried out by an independent Clinical Research Organization (CRO), which must therefore also be inspected and approved.  The results - both positive and negative - of dossier assessments and inspections are relayed carefully to manufacturers and CROs.

Related Links: