FPPs & APIs Eligible for Prequalification

The first step in the prequalification process of a finished pharmaceutical product (FPP) or active pharmaceutical ingredient (API) is its inclusion in an Invitation to Manufacturers to Submit an Expression of Interest for Product Evaluation (EOI). EOIs are issued by WHO, by therapeutic area, following consultation with WHO disease programmes and/or clinical specialists. Current EOIs relate to FPPs for treating HIV/AIDS, TB, malaria, neglected tropical diseases, diarrhoea, influenza or for reproductive health, and APIs used in the production of these FPPs.

FPPs invited for evaluation have been identified by WHO clinical experts as vital to effective treatment and expansion of treatment programmes, or to ensuring reproductive health. Generally, every product contained in an EOI is already included in the WHO Model List of Essential Medicines or the WHO Model List of Essential Medicines for Children, and/or in WHO treatment or other relevant guidelines. Exceptions may occur during, for example, a public health emergency when a product not yet included in the WHO Model List of Essential Medicines and/or in WHO treatment guidelines is nevertheless deemed vital for meeting treatment needs and invited for evaluation.

Eligible FPPs 

Invitations to manufacturers to submit an expression of interest (EOI) for product evaluation are currently open in the following therapeutic areas with respect to FPPs:

  • diarrhoeal disease
  • hepatitis B and C
  • HIV/AIDS
  • influenza
  • malaria
  • neglected tropical diseases
  • reproductive health
  • tuberculosis.

Eligible APIs

APIs used in the production of the FPPs included in the EOIs to FPP manufacturers are all eligible for prequalification, that is, selected APIs relating to the following therapeutic areas:

  • diarrhoeal disease
  • hepatitis B and C
  • HIV/AIDS
  • influenza
  • malaria
  • neglected tropical diseases
  • reproductive health
  • tuberculosis.