While the EMA is currently busy moving to the Netherlands and while the IDMP project currently seems to go slow, there is definite and significant progress being made in the background. The latest achievement is a major overhaul of the ISO/TS 19844 “Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances”.
The latest revision is providing details on the data elements specified in ISO 11238 (“Data elements and structures for the unique identification and exchange of regulated information on substances”) for agencies and vendors working on the substance repositories (such as G-SRS at the FDA or the substance repository at EMA). Most notable in this update is the detailed guidance on substance groups 1 – 3 with specifications on:
– data elements necessary for defining Substances and Specified Substances Groups 1 to 3
– the logical use of data elements as defined in ISO 11238
– Substances and Specified Substances Groups 1 to 3 business rules for:
– determining necessary data element
– distinguishing and defining materials according to ISO 11238
– triggering the assignment of identifiers
While previous version (2015 and 2016) did contain guidance on the same topics, the current revised version is filled with samples, more detailed specifications, and sample scenarios.
The last substance group, Substance Group 4 is not finally specified within the document and is expected to be addressed in a future revision of the document.