It is celebration day today (Jan 25) in Amsterdam at EMA headquarters. UNICOM is very pleased to announce that EU-SRS (the European Substances Registration System) is operational at EMA. The system is from now on hosted and maintained by EMA guaranteeing its overall sustainability and strategic use by the Substances Validation Group (SVG). The group is composed of substances related experts from the European National Competent Authorities (NCAs).
Several European NCAs and EMA, under leadership of the Medicines Evaluation Board (MEB), joined forces to establish EU-SRS for use by the European Medicines Regulatory Network (EMRN). The EU‑SRS system captures scientifically sound data on substances used in medicinal products; a major step towards IDMP compliance in Europe.
EU-SRS captures defining characteristics of substances, such as molecular structures, amino acid sequences and relationships. It has been a joint and sustained effort between various national agencies and EMA to implement EU-SRS, to cleanse substance data, to build substance records in EU-SRS and to create substance management guides for use by the SVG. Substance data cleansing results have been provided to EMA for further processing in their Substances Management Services system (SMS), resulting in a significant improvement of SMS data quality. Also, key substance information from EU‑SRS is or will be made available in SMS.
The EU-SRS implementation project HMA had been endorsed by the Heads of Medicines Agencies (HMA) in 2018. HMA had mandated the German Medicines Agency (Bundesinstitut für Arzneimittel und Medizinprodukte in Gernmany – BfArM) to host and maintain the EU-SRS system. The technical responsibility for the EU-SRS system has now been transferred from BfArM to EMA. While EMA is hosting and maintaining the EU-SRS system, the actual substance data remain maintained by the SVG.
Use cases of EU-SRS
The go-live of EU-SRS is the next step towards fulfilling a variety of use cases. For example, the system allows to perform similarity searches, provides insight in the characteristics of a substance, supporting the assessors during their work in the areas of quality, safety or pharmacovigilance assessments. Furthermore, it is an important step towards implementing structured data approach to drive regulatory submissions.
EU is using GSRS open source software
EU-SRS makes use of the Global Substance Registration System (GSRS) software, developed by the National Center for Advancing Translational Sciences (NCATS) team and FDA in the US, with input from substance experts from MEB and BfArM. The software is already in use by FDA, BfArM and the US Pharmacopeia (USP).
Access to the EU-SRS gradually extended
The access to the EU-SRS system will be gradually extended to the staff of EU National Competent Authorities in the upcoming period.