ERP News

IDMP: International Deadline Moved Provisionally

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This morning (September 2, 2015), the IDMP (Identification of Medicinal Products) External Working Group met. This group, led by FDA’s Vada Perkins, is a small set of vendors, pharmaceutical companies and regulators that are, for the most part, not part of the ISO Technical Committee 215 (TC-215), and others who are on the committee.

At this morning’s meeting it was reported by Andrew Marr and Anja von Haren that “it appears” that the deadline for IDMP in Europe will be moved to the end of 2017, for both medicinal products and substances. I said “it appears” because while there is consensus at the EU Heads of Medicines Agencies (HMA), no statement has yet been issued. The E2B group at ICH (the International Conference on Harmonisation, which is a coalition of US, Japanese and European pharmaceutical companies and regulators) has also said that the infrastructure to manage submission of IDMP data should be ready by mid-2017.

In related news, GInAS (the Global Ingredient Archival System) is nearing readiness for creation of substance data for IDMP. Its web interface has been revamped (it previously only worked in Chrome), and should be ready for production use in November. I’ll post more on GInAS shortly.

This does not mean that IDMP readiness projects should be put on hold for any more than a breath or two. Implementation of IDMP is a huge task, and this change in timing merely makes it possible to achieve it accurately, rather than an emergency-style, minimal quality, death march. CSC consultants will be available to assist in finding, and entering data into systems, as well as assisting on modernization of applications, data governance, and master data management.

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