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Update to IDMP Iteration 1

Written by Steve Scribner on 23/06/16

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
Summary of the 79 data elements required* for Iteration 1:
  • 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

Recommendation_for_EUNDB_approval.png

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Topics:
IDMP, ISO IDMP, XEVMPD






Steve Scribner

Written by Steve Scribner

Steve is a Consultant with 45 years of experience in computer solutions implementation in business. For the past 22 years, he has focused on electronic document/content management systems in the Pharmaceutical / Life Sciences industries. Steve has an extensive experience with managing multinational projects and looks for circumstances where his understanding of diverse cultures can help projects be successful. He has lived and worked in US, Western Europe and Asia.

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