A team of experts from the European medicines regulatory network (European Medicines Agency and national medicines authorities from the EU Member States), supported by experts from the US Food and Drug Administration (FDA) and US National Center for Advancing Translational Sciences (NCATS), are executing a project to implement a European Substance Registration System (EU-SRS). EU-SRS provides consistent scientific 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, in particular ISO 11238. EU‑SRS is making use of the Global Substance Registration System (GSRS) software developed in the United States of America by FDA and NCATS.
The information system is designed around the types of substances referenced in the ISO 11238 standard, e.g. chemicals, nucleic acids, proteins, polymers, structurally diverse, mixtures. The standardised scientific descriptions in EU-SRS enhance the review of (in)active substances in regulatory submissions pre- and post-authorisation. EU-SRS facilitates understanding of the relationships to other substances, as well as understanding of relationships to products from a quality and safety perspective.
The EU-SRS implementation project is known as Work Package 2 (WP2) within the UNICOM project and is also included in European Union Telematics Roadmap 2020/2021: https://www.ema.europa.eu/en/documents/other/extended-eu-telematics-strategy-implementation-roadmap-2020-2021_en.pdf.
EU-SRS implementation – Project execution
The EU-SRS project is funded by a combination of in-kind contributions as well as funding through UNICOM (Work Package 2). The project has several components:
The EU-SRS system will be installed, validated and made available for the European medicines regulatory network.
Data cleansing to be completed by 2022
Available substance data from EMA is being cleansed and will be made available in EU-SRS. Data cleansing is essential as substance names are not always unique and unambiguous with synonyms, including systematic, common, official and code names being available. For this purpose a Substance Validation Group (SVG) was already established and started substance data cleansing in 2019, when a proof of concept project took place to assess feasibility of the EU-SRS implementation. The SVG continues their work in 2020 and aims to complete the work by 2022. The results of data cleansing will be implemented in the EMA Substance Management Service (SMS) , and through SMS will be synchronized to other regulatory systems to support the electronic submission of applications for EU procedures (e.g. eAF, XEVMPD, EUTCT).
Processes & governance to maintain the EU-SRS system
Processes for maintaining substance data as well as for maintaining the EU‑SRS system will be established. This should ensure that also when the initial data cleansing activities are completed, the quality of the substance data in EU-SRS remains high. Also, in order to deliver a sustainable solution, governance needs to be in place, and a funding schema for the substance maintenance work delivered by substance experts from the EU national medicines authorities needs to be arranged.
Key documents to be released
The first deliverable of the EU-SRS project was an endorsed EU-SRS implementation plan. The implementation plan was endorsed in March 2020 by the Heads of Medicines Agencies (HMA). This endorsed EU-SRS implementation plan is now being executed by the EU-SRS Project Team and SVG. The anticipated go live date of EU-SRS is end of Q1/2021.
The first results are available for sharing outside the project team:
Data cleansing manual – first release
The data cleansing manual has been written to serve as a reference during data cleansing activities performed by the SVG and to ensure alignment between the SVG and EMA. It aims to provide practical guidance and examples to handle different Substance Types during data cleansing activities. This manual is a living document and only provides guidance to Substance Types for which data cleansing has been initiated. Currently, the document has been written based on experiences with regards to Chemicals and Proteins.
Data cleansing interim results
This excel sheet provides insight in which EMA substance records were cleansed by the SVG and for which required changes were implemented in EMA’s SMS, and therefore are available to the European regulatory network. The nature of the implemented changes are also explained.
In case of questions, feel free to contact us:
- (project leader EU-SRS implementation project)
- (SVG coordinator)
- EMA Service Desk