D2.7 Documentation to hand-over the EU-SRS system to a maintenance organization

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under the Grant Agreement No. 875299 ${If.End}${If.App.PowerPoint} ${If.End} Project acronym: UNICOM Project full title: Up-scaling the global univocal identification of medicines in the context of Digital Single Market strategy Call identifier: H2020-SC1-DTH-2019 Deliverable D2.7: Documentation to hand-over the EU-SRS system to a maintenance organization Version: 1.0 Status: Final Dissemination Level 1 : PU Due date of deliverable: 31.01.2023 Actual submission date: 14.08.2023 Work Package: WP2: IDMP – Substance Management in Europe Lead partner for this deliverable: CBG Partner(s) contributing: BfArM Deliverable type 2 : Demonstrator Main author(s): Name A. Rozema CBG Other author(s): 1 Dissemination level: PU: Public; CO: Confidential, only for members of the consortium (including the Commission Services); EU-RES: Classified Information: RESTREINT UE (Commission Decision 2005/444/EC); EU-CON: Classified Information: CONFIDENTIEL UE (Commission Decision 2005/444/EC); EU-SEC Classified Information: SECRET UE (Commission Decision 2005/444/EC) 2 Type of the deliverable: R: Document, report; DEM: Demonstrator, pilot, prototype; DEC: Websites, patent fillings, videos, etc.; OTHER; ETHICS: Ethics requirement; ORDP: Open Research Data Pilot UNICOM – D2.7: Documentation to hand-over the EU-SRS system to a maintenance organization Page 2 of 10 Revision history Version Date Changes made Author(s) 0.1 25/07/2023 Initial version Annet Rozema 1.0 02/08/2023 Final version Annet Rozema Statement of originality This deliverable contains original unpublished work except where clearly indicated otherwise. Acknowledgement of previously published material and of the work of others has been made through appropriate citation, quotation or both. UNICOM – D2.7: Documentation to hand-over the EU-SRS system to a maintenance organization Page 3 of 10 Deliverable abstract EU-SRS is making use of G-SRS Software developed by the US FDA and NCATS. In preparation for the go-live of EU-SRS, the software was validated. The validation took place at EMA since EMA will host and maintain the software on behalf of the EU regulatory network. The validation was successful, and the associated documentation was handed-over to EMA and uploaded to their document management system called Dream. The official hand-over of EU-SRS to EMA was performed during the F2F meeting at EMA on January 24,25,26 of 2023. Soon after this meeting, the scanned validation documentation was provided to EMA. The EMA technical team added the necessary technical information to the documentation. This was the result of a joint effort between the EMA Architect and the EU-SRS software developer. Keywords: Validation, EU-SRS, G-SRS This document contains material, which is the copyright of the members of the UNICOM consortium listed above, and may not be reproduced or copied without their permission. The commercial use of any information contained in this document may require a license from the owner of that information. This document reflects only the views of the authors, and the European Commission is not liable for any use that may be made of its contents. The information in this document is provided “as is”, without warranty of any kind, and accept no liability for loss or damage suffered by any person using this information. © 2019-2023. The participants of the UNICOM project. UNICOM – D2.7: Documentation to hand-over the EU-SRS system to a maintenance organization Page 4 of 10 TABLE OF CONTENTS Revision history ....................................................................................................................................... 2 Deliverable abstract ................................................................................................................................. 3 List of abbreviations ................................................................................................................................. 6 Summary ................................................................................................................................................. 7 1 Go-Live EU-SRS and hand-over to EMA ......................................................................................... 8 2 EU-SRS system hosted and maintained by EMA ............................................................................ 9 3 EU-SRS maintenance by EMA ...................................................................................................... 10 3.1 EMA User Access Management ............................................................................................ 10 3.2 Software upgrade .................................................................................................................. 10 3.3 R&D Value Stream ................................................................................................................ 10 UNICOM – D2.7: Documentation to hand-over the EU-SRS system to a maintenance organization Page 5 of 10 LIST OF FIGURES Figure 1. Overview of validation documentation for EU-SRS ................................................................. 7 Figure 2. Transfer of EU-SRS hosting and maintenance to EMA ........................................................... 8 Figure 3. Screenshot of the homepage of SVG-SRS, hosted by EMA ................................................... 9 Figure 4. Screenshot of a chemical substance record in SVG-SRS ....................................................... 9 UNICOM – D2.7: Documentation to hand-over the EU-SRS system to a maintenance organization Page 6 of 10 List of abbreviations Abbreviation Complete form BfArM Bundesinstitut für Arzniemittel und Medizinprodukte EMA European Medicines Agency EU-SRS European Substance Registration System FDA Food and Drug Administration G-SRS Global Substance Registration System IDMP Identification of Medicinal Products ISO International Organization of Standardization NCATS National Center for Advancing Translational Sciences SMS Substance Management Services SVG Substance Validation Group SVG-SRS EU-SRS system for use by the SVG to maintain substances records WP Work Package UNICOM – D2.7: Documentation to hand-over the EU-SRS system to a maintenance organization Page 7 of 10 Summary UNICOM WP2 aims to create an EU regulatory network-wide accessible, structured database, referred to as the EU substance registration system (EU-SRS), for the identification of substances in medicinal products based on their scientific properties in accordance with ISO IDMP standard 11238 and ISO implementation standard 19844. EU-SRS uses the open-source software called G-SRS (Global Substance Registration System) developed by FDA/NCATS. FDA has classified the software as “Governmental off-the-shelf”, which was taken into account in defining the validation approach. The validation manager of the EU-SRS project guided the validation process with the following key deliverables. Figure 1. Overview of validation documentation for EU-SRS The EU-SRS team delivered documents belonging to topics 1, 2, 3, 5, 6 and 7. EMA took care of topic 4, the EU-SRS technical documentation. The technical documentation was prepared by Andrei Idu (EMA, Architect) and Egor Puzanov (BfArM/EMA). During the transfer of responsibilities from BfArM to EMA, the consultant responsible for the technical EU-SRS matters was also transferred from BfArM to EMA, which was appreciated from a risk mitigation perspective. After the validation activities were performed, EMA performed a penetration test. This was also successful. UNICOM – D2.7: Documentation to hand-over the EU-SRS system to a maintenance organization Page 8 of 10 1 Go-Live EU-SRS and hand-over to EMA During the EU-SRS implementation project, BfArM hosted the software. The end goal was, however, to have EU-SRS up and running and validated at EMA. This means that there was an official hand-over to EMA, where EMA was represented by Hilmar Hamann, the CIO of EMA. The hand-over took place during a ceremony at EMA on January 24, 2023. Figure 2. Transfer of EU-SRS hosting and maintenance to EMA UNICOM – D2.7: Documentation to hand-over the EU-SRS system to a maintenance organization Page 9 of 10 2 EU-SRS system hosted and maintained by EMA The images below show an overview of the system. At the time of handover to EMA, over 60k substances records are available in the SVG-SRS system. 18k records are chemical records, of which almost all are ready for publishing. The SVG will process the concept records as part of their day-to-day work on substances. The URL points to the location of EU-SRS at EMA. Figure 3. Screenshot of the homepage of SVG-SRS, hosted by EMA The following image is an example of a chemical substance in the SVG-SRS. Figure 4. Screenshot of a chemical substance record in SVG-SRS