Coming Up to ISO IDMP Standards

ABSTRACT

A revised series of standards from the International Organization for Standardization (ISO), the identification of medicinal products (IDMP), were formulated for the creation of an integrated global data source for medicinal products (1). From an International Council for Harmonization (ICH) perspective, the standardized product identification would be able to support multiple processes, but in the EU, new legislation came into force in 2016 concerning data submission on authorized medicines, to primarily optimize connection of pharmacovigilance (PV) signals to products. ingredients, batches, and so on, using standardized data, replacing the existing Article 57 database. XEVMPD provides for more limited data fields than are required for IDMP submissions, but it has paved the way for data exchange as a means of product information delivery and discovery, reducing reliance on static documents. Making a fundamental change to regulatory information management approaches now, then, is likely to pay dividends in the long run-once multiple documents can be built from one definitive data set based on agreed international standards.