FPPs & APIs Eligible for Prequalification ("EOIs")
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, covid-19 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:
- apnoea in preterm infants
- COVID-19
- diarrhoeal disease
- ebola virus disease
- hepatitis B and C
- HIV/AIDS
- infections in newborn and young infants and childhood pneumonia
- influenza
- malaria
- multi-drug resistant bacterial infections
- neglected tropical diseases
- reproductive health
- tuberculosis
- tobacco use
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:
- apnoea in preterm infants
- COVID-19
- diarrhoeal disease
- hepatitis B and C
- HIV/AIDS
- infections in newborn and young infants and childhood pneumonia
- influenza
- malaria
- multi-drug resistant bacterial infections
- neglected tropical diseases
- reproductive health
- tuberculosis
1st - EOI for caffeine citrate for treatment of apnoea in preterm infants (3 October 2024)
8th - EOI for FPPs for COVID-19 (29 March 2022)
1st - EOI for zinc FPPs for diarrhoeal disease (10 November 2016)
2nd - EOI for FPPs for Ebola Virus Disease (25 May 2023)
5th - EOI for FPPs for hepatitis B and C (25 October 2022)
21st - EOI for FPPs for HIV/AIDS (8 May 2024)
4th - EOI for FPPs for influenza-specific antiviral medicines (19 August 2024)
22nd - EOI for FPPs for malaria (19 October 2023)
1st - EOI for FPPs for treatment of multi-drug resistant bacterial infections (30 March 2023)
8th - EOI for FPPs for neglected tropical diseases (8 April 2024)
Diarrhoeal disease
The treatment of diarrhoea: a manual for physicians and other senior health workers (2005)
HIV/AIDS, hepatitis B and C
Influenza and other influenza viruses
Malaria
WHO guidelines for malaria (16 February 2021)
Reproductive health
Various WHO reproductive health guidelines
Tuberculosis
- WHO consolidated guidelines on tuberculosis: module 1: prevention: tuberculosis preventive treatment
- WHO operational handbook on tuberculosis: module 1: prevention: tuberculosis preventive treatment
- WHO consolidated guidelines on tuberculosis Module 2: Screening – Systematic screening for tuberculosis disease
- WHO operational handbook on tuberculosis Module 2: Screening – Systematic screening for tuberculosis disease
- WHO consolidated guidelines on tuberculosis Module 3: Diagnosis - Rapid diagnostics for tuberculosis detection
- WHO operational handbook on tuberculosis Module 3: Diagnosis - Rapid diagnostics for tuberculosis detection
- WHO Consolidated Guidelines on Tuberculosis, Module 4: Treatment - Drug-Resistant Tuberculosis Treatment
- WHO Operational Handbook on Tuberculosis, Module 4: Treatment - Drug-Resistant Tuberculosis Treatment
- WHO Consolidated Guidelines on Tuberculosis, Module 4: Treatment - Drug-Susceptible Tuberculosis Treatment
- WHO Operational Handbook on Tuberculosis, Module 4: Treatment - Drug-Susceptible Tuberculosis Treatment