Workshop on implementation of revised expedited procedure for registration of prequalified vaccines
8–9 December 2014, Istanbul, Turkey
WHO will hold a workshop to support implementation of the new procedure in countries that use prequalified vaccines; the event will introduce the procedure, and explain the process and commitments of WHO, national regulatory authorities and applicants.
Participants will include managers of national immunization programmes, heads of national regulatory authorities and authority staff in charge of registration, and staff in charge of review of registration dossiers from 20 Member States, along with WHO staff and advisers.
The procedure for expedited review of imported prequalified vaccines for use in national immunization programmes has been revised, in line with those for prequalification of pharmaceutical products and for assessing the acceptability in principle of vaccines for purchase by United Nations agencies. The revised procedure aims to provide a convenient tool for national regulatory authorities wishing to enhance their pre-marketing evaluation and registration systems by taking advantage of WHO’s scientific assessments.
The new procedure is expected to facilitate planned vaccine-related activities within the framework of Polio Eradication and Endgame Strategic Plan, such as introduction of inactivated polio vaccine and the global shift to the use of bivalent oral polio vaccine.