IDMP version 2.0 has been published

Version 2.0 of the European implementation guidance for IDMP has been finally published. Time is of the essence, so nothing catches you by surprise!

Version 2.0 of the European implementation guidance for IDMP has been finally published. Time is of the essence, so nothing catches you by surprise!
February 22, 2021

Version 2.0 of the European implementation guidance for IDMP has been finally published. Time is of the essence, so nothing catches you by surprise!

 This version will not capture all industry comments, but it will cover the most important ones. Versions 2.1 and 2.2 are planned for Q2 and Q3 2021 respectively, with significant improvements and more examples.

This guide sets the clock start of a minimum of 12 months for the PMS (Product Management Service) go-live. A user interface (UI) will be released to manage data in the new format during the transition period, which will take at least another 12 months. After this period, submissions in IDMP format (FHIR) for centralised procedures (CAPs) will be mandatory. There will be an official publication at some point during this transition period which will mark the 12 months deadline until mandatory implementation.

In CAPs, the submission will be performed in FHIR format during the procedure, including it in the eCTD. The final message of the closing sequence is the one that will be uploaded to the PMS, and will feed xEVMPD.

For non-centralised procedures the process is not fully defined, but in principle in this first phase the submission in FHIR format will be performed post-authorisation and not within the eCTD.

Make sure to check the updated website and contact us if you need any further help or assistance.

Search News & Events

  • Filter by category

Share

Related news and events

2nd eAF (DADI) Newsletter has been published on the EMA website!

2nd eAF (DADI) Newsletter has been published on the EMA website: The web-based Human Variations electronic application form (eAF) for Centrally Authorised Products (CAPs) – often referred to by its former project name, DADI – has been available for use as of 4 November 2022 on the new Product Lifecycle Management (PLM) Portal.

Cena Navidad AEFI 2022 ASPHALION

AEFI ‘Xmas dinner

Una representación de expertos de Asphalion acudió anoche a la tradicional cena de Navidad de la Sección Catalana de AEFI en Barcelona. En Asphalion somos

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting