Flyer: Virtual Workshop on Documentation Format Requirements and Principles of Assessment for WHO Prequalification and Emergency Use Listing of Vaccines

Overview

One of the major obstacles to the access of health products, including vaccines, is the delay in their approval by regulatory authorities after submission of product applications by manufacturers. Poor quality submissions and inadequate data provided by manufacturers have been identified as main obstacles by regulatory authorities. This workshop, organized by the WHO Local Production and Assistance Unit, with financial support from the Bill & Melinda Gates Foundation (BMGF), aims to enhance the understanding and promote best practices amongst manufacturers, particularly in low- and middle-income countries, on quality requirements for vaccines as described in the guidelines of WHO and other regulatory authorities for prequalification and licensing purposes.