Module 9 2021
23/03/2021
WHO prequalification (vaccines) – principles Full title of procedure: “WHO Procedure for assessing the acceptability, in principle, of vaccines for purchase by UN Agencies”
Link to: WHO Vaccines PQ Procedure (WHO TRS 978, Annex 6)
Cf. Section 1 and 2
Intended as surrogate to local licensure, where there is no local RA infrastructure or it is weak. Not intended to replace local licensure, when a process exists; but can help to expedite local approval
Includes full regulatory review(*) (with special focus
Service provided by WHO to UN agencies: Mechanism by which WHO assesses quality, efficacy and safety of product supplied to UN agencies
Relies on license in country of manufacture (National Regulatory Authority must be « functional »)
on relevance of data to target population), lot testing(*), GMP inspection(*), and Programmatic Suitability aspects (PSPQ)
(*) Can be waived in case of PQ based on oversight by «Stringent»/«Mature» Regulatory Authority (Streamlined PQ)
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WHO Prequalification – Overall Process
Marketing authorisation (country of manufacture)
Prequalification
WHO/Access to Medicines and Health Products/Regulation and Prequalification (RPQ)/ Prequalification Team (PQT)
Vaccine
Letter to UN agencies
Supply to UN Agencies
UNICEF, PAHO,…
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