From 12/04/2022 onward, EMA is publishing the non-confidential substances data from their SMS system. Each substance will have a flag to indicate whether or not this substance was cleansed. The data will be published on a daily basis, on the EMA SPOR portal, in CSV format. For the team working in UNICOM WP2, this means that the results of the tremendous efforts by the Substance Validation Group members will finally become usable by the outside world.
Setting up a collaboration process with the Industry
On April 6, at the Global Pharmaceutical Regulatory Affairs Summit conference in Berlin, Annet Rozema from CBG in the Netherlands highlighted the goals of the European Substance Reference System (EU-SRS) project and the project status presented on EU-SRS. This was a joint presentation with Jean-Gonzague Fontaine of the pharmaceutical company GSK who shared his view on how industry and regulators could & should work together in substances management. In the EU-SRS implementation project, industry will be involved in building vaccines substances in the SRS system, by installing the GSRS software within their companies and exchanging vaccines substances JSON files”.