Are you ready? Have you implemented EU ISO IDMP standards for medicinal products?

by: Barbara Polello – Pharmacovigilance Compliance Expert @PQE Group

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.

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Regulators push to establish high levels of interoperability across global regulatory and healthcare communities. Interoperability guarantees that different information systems can access, integrate information, share and cooperatively use data in a coordinated manner, within and across organizational, regional and national boundaries, to provide timely and seamless portability of information and optimize the health of individuals and populations globally.

The implementation of EU ISO IDMP standards in your organization provides a great opportunity to align master data internally, among different areas and departments.

Are you prepared for the EU ISO IDMP implementation?

PQE Group can support your business with your Master Data Management Strategy and in implementing the new standards.

To get more information or support, get in touch with our RA Team  or check our Regulatory Affairs dedicate page to find the most suitable solution for your company.