The ISO IDMP Task Force met in April to compile recommended changes to the content of the information model. A revised draft version was scheduled for vote in the meeting on May 12. A revised timeline was also on schedule to be discussed. We will publish an update in the next blog.
Several highlights to the content changes include:
- Allow cross-references from one generation submission to another (e.g. IND to NDA or CTA to MAA) or to another, different medicinal product.
- Add Orphan Designation
- Updates to Marketing Status
- Delete PSUR (already handled by other standards)
- Added Ingredient Manufacturer
- 28 existing from XEVMPD
- 14 redefined from XEVMPD
- 33 new elements, including:
- 9 for Medicinal Product Name
- 5 for Marketing Authorization
- 6 for Pharmaceutical Product
- 6 for Packaging
- 3 for Manufacturing items
- 6 others (Clinical Particulars, Ingredients, etc.)
* The model may still be modified. It is not yet final.
Picture 1: Recommendation for EUNDB approval