The European Medicines Agency (EMA) has started its multi-year programme, which defines a Master Data Management (MDM) strategy for the use of medicinal product data specifically related to Substance, Product, Organisation and Referential (SPOR) data.
The EMA is delivering four SPOR data management services for the centralized management of master data that comply with ISO IDMP standards. SPOR services support the implementation of ISO IDMP standards in the EU / EEA, and will facilitate the reliable exchange of medicinal product information in a robust and consistent manner, fully in line with the “one-stop-shop” approach to have a single comprehensive source of data via one service.
Companies must implement IDMP standards for submission of data for centralized and non-centralized products by following a defined timeline. Company policies, procedures and systems must be rapidly and effectively adapted in order to implement IDMP standards. Company IT systems may require an integration or migration.
Make clear where your organization is in this process, determine your goal and set an agile project plan to quickly adapt the organization (quality system, documents and data management) and its infrastructure to ensure your company’s data management program is ready for the new IDMP requirements and newly established interoperable regulatory information systems.