Module 9 2024

03/09/2024

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: Health products policy and standards (who.int)

Cf. Section 1 and 2

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 »)

Includes full regulatory review(*) (with special focus on relevance of data to target population), lot testing(*), GMP inspection(*), and Programmatic Suitability aspects (PSPQ)

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

(*) Can be waived in case of PQ based on oversight by «Stringent»/«Mature» Regulatory Authority (Streamlined PQ)

The Organisation for Professionals in Regulatory Affairs

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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,…

Illustrative figure courtesy of GSK

The Organisation for Professionals in Regulatory Affairs

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