WHO informal consultation on revision of the WHO guidelines on regulatory preparedness for provision of marketing authorization (MA) of human pandemic influenza vaccines in non-vaccine producing countries - Revision to Annex 7 of TRS No 1004

Overview

During the two and a half-day meeting (April 17-19th, 2023), representatives from various WHO member states, philanthropic organizations, and WHO teams/affiliations met in Istanbul, Turkey, to revise the draft guidance in consideration of the feedback received from the first public consultation. In addition to addressing the feedback, meeting participants heard from representatives of various member state National Regulatory Authorities (NRAs) with experiences related to the importation of vaccines during the recent SARS-CoV2 pandemic. Representatives were requested to comment on the regulatory status of the country prior to and during the pandemic with respect to their regulatory preparedness for the importation and authorization of vaccines, challenges encountered or lessons learned, and their future expectations of the WHO related to pandemic preparedness. Representatives’ input and experiences were discussed and considered throughout the meeting and incorporated into the revision of the draft guidance.