Table 1.
Evolution of the WHO prequalification procedure for vaccines: 1987–2010.
| Characteristic | 1987 | 1989 | 1997 | 2002 | 2005 | 2010 | |
|---|---|---|---|---|---|---|---|
| Pre-conditions for acceptance of submissions | |||||||
| None required but concept of reliance on NRA already present | |||||||
| Functionality of NRA as pre-requisite for submission | |||||||
| Requires MA in country of origin or EMEA Scientific Opinion (Art. 58) | |||||||
| WHO recommendations or guidelines are available | |||||||
| Candidate vaccine present on list of priority products for prequalification | |||||||
| Candidate vaccine meets mandatory characteristics for Programmatic Suitability for Prequalification (PSPQ) (Ref) | |||||||
| Assessment procedure | |||||||
| Technical evaluation of quality, safety and efficacy | Copy of licensure by NRA in country of origin and other documents. | ||||||
| Requires submission of Product File containing limited information | |||||||
| Requires submission of Product Summary File (PSF) with defined format and contents (10 Chapters) | |||||||
| Acceptance of Common Technical Document (CTD) as alternative to PSF | |||||||
| Strengthened requirements for demonstration of clinical efficacy and safety | |||||||
| Requires application letter in advance to actual submission of PSF | |||||||
| Pre-evaluation meetings between manufacturer and WHO-PQ and NRA | |||||||
| Screening of files for compliance in format and contents prior to formal review | |||||||
| Increased focus on the suitability of product characteristics to the target NIP | |||||||
| Compliance with PSPQ mandatory characteristics | |||||||
| Deviation from critical characteristic triggers referral to PSPQ standing committee | |||||||
| Consistency | Independent testing of samples, review of release certificates and SLP | ||||||
| Inspection/site visit/site audit | Inspection: focus on production, quality control and records | ||||||
| Inspection: team of experts, one WHO staff plus one representative from NCL | |||||||
| Site visit: additional focus on Quality Assurance and GMP | |||||||
| Site visit: team of experts on each area, WHO staff, representative of NRA and UN agency representative may elect to join | |||||||
| Written report sent to manufacturer. Improvements may be required before decision | |||||||
| Debriefing sessions to manufacturer held on daily basis and on final day | |||||||
| Availability of reports of recent inspections conducted by NRAs may be used to streamline the audit by WHO | |||||||
| Ad hoc committee on PQ to advise on final outcome of the evaluation when needed | |||||||
| Consultation meeting with responsible NRA to discuss regulatory status of the vaccine and to agree on future information sharing (nature and mechanism) | |||||||
| Collaboration arrangements are signed with NRA for information sharing | |||||||