Collaborative Procedure Between the World Health Organization (WHO) Prequalification Team and National Regulatory Authorities in the Assessment and Accelerated National Registration of WHO-prequalified Pharmaceutical Products and Vaccines. WHO Technical Report Series, No. 996, 2016, Annex 8
(2016; 42 pages)

Abrégé

National assessment of applications for registration of pharmaceutical products and vaccines (marketing authorization) is the key regulatory process that enables NRAs to evaluate and monitor the quality, safety and efficacy of pharmaceutical products and vaccines.

Consideration of the outcomes of assessments and inspections by authorities, whose regulatory decisions are based on acceptable standards, substantially contributes to savings in regulatory resources and improvements in the quality of regulatory decisions, while retaining the prerogative of NRAs to conclude their assessment by sovereign decisions, which reflect their own judgement of the benefit–risk balance as it relates to their specific country situation and the legislation in place.

To enhance timely access to prequalified products in countries, to ensure that the product in countries is the same as the one which is prequalified and to provide a model for regulatory information exchange among countries, this Procedure has been developed based on the above-mentioned considerations. In line with the Procedure for prequalification of pharmaceutical products and the Procedure for assessing the acceptability in principle of vaccines for purchase by United Nations agencies it aims to provide a convenient tool for NRAs wishing to enhance their premarketing evaluation and registration system by taking advantage of the scientific assessment work conducted by WHO/PQT. For pharmaceutical products the present procedure is complementary to the WHO/PQT collaborative procedure with NRAs in inspection activities (http:// www.who.int/prequal, "Inspections").

The collaborative procedure was first piloted in June 2012 and is currently in use for pharmaceutical products (http://www.who.int/prequal, "Collaborative Registration"). For vaccines another procedure for expedited review of imported prequalified vaccines for use in national immunization programmes was published in 2007 and has been implemented for national registrations since 2010. However, this procedure did not include collaborative arrangements with the NRAs. In 2010 WHO/PQT piloted an expedited registration procedure that involved sharing of the WHO/PQT assessment reports with the NRAs.

This collaborative procedure also benefits manufacturers of prequalified pharmaceutical products and vaccines through faster and better harmonized regulatory approvals in participating countries. This Procedure, when combined with the WHO/PQT collaborative procedure with NRAs in inspection activities, alleviates the burden of additional national inspections on manufacturers.

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