Workshop on Procedure for Expedited Review of Imported Prequalified Vaccines for Use in National Immunization Programmes
3-7 December 2012 - Manila, Philippines
The majority of countries procuring vaccines through either the United Nations or independent mechanisms in the Western Pacific Region are yet to implement registration and licensing based on WHO standards, primarily due to lack of human resources.
WHO developed the "Expedited Review Procedure" for imported prequalified vaccines for use in national immunization programmes in 2006. This procedure is intended to support countries with limited resources and who are procuring vaccines from the United Nations prequalified list to establish their registration and licensing procedures.
The Expedited Review Procedure will be presented in eight selected countries in the Region for the first time. This workshop will build the capacity of these countries to establish registration and licensing procedure through a short, expedited and well-tested process. This procedure will also facilitate vaccine registration and licensing during any disease outbreak or pandemic.
- To provide training on the Expedited Review Procedure using new tools including the database to evaluate the registration and licensing documents and to assess required samples;
- To discuss requirements and processes for the introduction of Expedited Review Procedure of imported prequalified vaccines in selected countries; and
- To develop a country plan of action to establish and implement the registration and licensing.