While the booster vaccination against Covid-19 is proceeding at full speed 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 GSRS 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) collaborative centre 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 a feasibility assessment of globalization of substance management, using the GSRS software. The starting point of this discussion was COVID vaccines. The “Global Vaccines Initiative” team investigated the feasibility from different angles: technical feasibility, work processes, and alignment on the content, in other words aligning the way vaccines are to be described in the SRS systems and being the foundation for a global substance identifier.
The conclusions from the Global Vaccines Initiative were that globalization of substance management is feasible. There is a strong willingness to continue working together towards a global approach in substance management, and to also involve industry in this activity. Industry is an important stakeholder in substance management; they have expressed their interest to join this initiative and they support the move to a more data-driven approach in substance management.
Early 2022, the team expects to further clarify the approach taken moving forward.