WHO Workshop on Implementation of Guidelines for procedures and data requirements for changes to approved vaccines

Overview

Regulation of changes to approved vaccines is one of the most important elements in ensuring that the vaccines of consistent quality, are distributed after they receive authorization or licensure. In response to the request from National Regulatory Authorities (NRAs) of the World Health Organization (WHO) Member States on the data needed to support changes to approved vaccines to ensure the comparability with respect to quality, safety and efficacy of vaccines manufactured with the change, WHO have developed Guidelines for procedures and data requirements for changes to approved vaccines. These guidelines were adopted by Expert Committee on Biological Standardization (ECBS) in its meeting 2014 and published in the WHO Technical Report Series 993. The Guidelines provide guidance to NRAs and manufacturers on the essential data required to support the change, which does not negatively impact on the quality, safety and efficacy of the vaccines and also provide regulatory procedures to review and approve the changes submitted by manufacturers.

To facilitate the implementation of these guidelines, a three-day workshop was organized by the WHO Headquarters with assistance from the WHO country office in Viet Nam, NRA and vaccine manufacturers who are responsible for regulation of post-approval changes in their institution, at Green One UN House in Hanoi, from 7-8 August 2019.