The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP).
Commission Implementing Regulation (EU) No 520/2012 (articles 25 and 26) obliges European Union (EU) Member States, marketing authorisation holders and EMA to make use of the ISO IDMP standards. This will impact on many areas of the pharmaceutical.
Their purpose is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner. In comparison to xEVMPD, the current legislative format, IDMP is substantially more detailed and complex.
They help to ensure wide interoperability across global regulatory and healthcare communities, which is critical in ensuring accurate analysis and unambiguous communication across jurisdictions.
EMA is delivering four SPOR data management services for the centralised management of master data that comply with the ISO IDMP standards.This programme based on the four domains of master data in harmaceutical regulatory processes:
Referential (SPOR) master data
ISO IDMP covers the entire product lifecycle: products in development, investigational products, products under evaluation and authorised products.
Is your regulatory information management system up to IDMP?
Contact us to know more about the steps to follow for its correct implementation.