Vaccine manufacturers, regulators complete training on CTD format

eAwaz Medicine

Washington – The Local Production & Assistance (LPA) Unit in the Regulation and Prequalification Department, WHO, successfully completed training of about 800 vaccine manufacturers and regulators from over 60 countries in the six WHO regions on the format and documentary requirements of a vaccine dossier for a WHO prequalification (PQ) and Emergency Use Listing (EUL) application.

One cause for delays in timely registration and access to vaccines, particularly in low- and middle-income countries (LMICs), is submitting incomplete vaccine dossiers to regulators. The Virtual Training Workshop on the Documentation Format Requirements and Principles of Assessment for the WHO Prequalification and Emergency Use Listing of Vaccines, organized by the Local Production and Assistance Unit from 28 June to 1 July 2022, built the manufacturers’ and regulators’ understanding, particularly in LMICs, on the common technical document (CTD) format and quality requirements for vaccines as described in the guidelines of WHO for PQ/EUL and other regulatory authorities for registration.