Immunization standards

Revised procedure for expedited review of imported prequalified vaccines for use in national immunization programmes

The procedure for expedited review of imported prequalified vaccines for use in national immunization programmes has been revised in line with the Procedure for prequalification of pharmaceutical products (1), and the Procedure for assessing the acceptability in principle of vaccines for purchase by United Nations Agencies (2) . The revised procedure aims at providing a convenient tool for National Medicines Regulatory Authorities (NMRAs) wishing to enhance their pre-marketing evaluation and registration system by taking advantage of the scientific assessment work conducted by the World Health Organization Prequalification Team (WHO/PQT). The title of the procedure is Collaborative procedure between the World Health Organization Prequalification of Medicines Programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO‑prequalified pharmaceutical products and vaccines.

Although the previous procedure relied on the review of Lot summary protocol, samples and summary information provided by the manufacturer and WHO/PQT, the Vaccine Prequalification team successfully applied a pilot support strategy in 2010 during facilitation of the license of the Meningococcal A conjugate vaccine for use in countries of the African meningitis belt. This facilitated procedure included sharing of the assessment report, results of laboratory testing and inspection reports, which are all components of the current revised procedure.

The most important advantages of the new procedure are:

  • The evaluation procedure is set as a collaboration between participating National Regulatory Authorities (NRAs) and WHO/PQT with consensus from the manufacturer.
  • There is an agreement between WHO/PQT and NRAs, by which WHO/PQT shares the assessment reports, inspection reports, and laboratory results via a secured site to designated NRA focal persons.
  • The company submits to the NRA the dossier in product summary file (PSF) format, and sends written agreement to WHO/PQT to share information with the NRA. The Company pays the fees directly to the NRA.
  • The NRA signs with WHO/PQT a confidentiality agreement and a commitment to use PQ reports as basis for accelerated review and decision within 90 days of acceptance of the application. If the decision is negative, the NRA must inform WHO/PQT and justify differing decision via restricted access site.
  • The procedure includes provisions for variations and for notification of suspensions and withdrawals of prequalified product both ways (NRAs and WHO/PQT).
  • The company is requested to notify NRA and WHO/PQT that they are interested in using this procedure before submission to NRA.
  • The procedure applies to each product independently.
  • Several countries have already signed agreements to use the procedure for pharmaceutical products, so the new agreement would be for extension to vaccines.

Kindly provide any comments you may have on this revised procedure by email to vaccprequalification@who.int by 9 September 2014.

The revised procedure can be found at the following link:

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Last update:

29 July 2014 17:13 CEST