While vaccination against Covid-19 is now accelerating in most European countries and worldwide, the question of the correct identification and global alignment on vaccines substances is still for now an open issue that UNICOM has decided to prioritize.
UNICOM WP2 key objective is to implement EU-SRS (European Substance Registration System): The system provides scientifically sound descriptions of substances used in medicinal products in the EU by applying regulatory standards for the identification of medicinal substances in accordance with the ISO IDMP standards. This is a core central element for the identification of medicinal products, including thus vaccines.
The open-source SRS software is now increasingly used by key regulatory bodies at national and global level (including FDA) providing thus new accelerated technical alignment possibilities in a secure environment ((import/export of substance data, confidentiality, security).
Both WHO (World Health Organisation)-UMC (Uppsala Monitoring Centre) and FDA (Federal Drugs Administration USA)-NCATS (National Center for Advancing Translational Sciences) have expressed their willingness and interest in working jointly on describing substances of COVID vaccines, to try to align working methods and use the COVID situation as a trigger to urgently work on a global approach to substance management.
Starting from best practices, UNICOM WP2 has thus initiated a new task aiming at performing a feasibility assessment of global alignment in managing vaccines substances, including antigens and adjuvants present in vaccine products together with the Naming and substance IDs.
The final conclusions of this global initiative, foreseen for September 2021, will also contain the advice on a possible workflow between FDA, EU-SRS and WHO and propose next concrete steps.