Updated DADI Human Variations Form Timeline and revised go-live scope.

The European Medicines Agency (EMA) updated the timeline for the IDMP DADI project on 24 May 2022.

But what exactly was this project about? Here is a short reminder: Its target is to replace the current electronic application form with a web-based form that uses data from the SPOR database and exports it as an application form PDF. In the initial release, planned for October 2022, the scope will, first, allow conversion of the current interactive PDF format eAF to the new web-based format. Future releases will progressively oust free-fillable data fields, replacing them with structured ones. Additionally, the web forms will introduce the mandatory use of Organization Management Service (OMS) for all procedure types, an innovation for non-Centralized procedures.

The updated timeline contains the following modifications:

  1. The limited User Acceptance Testing (UAT) phase was prolonged to the third quarter of 2022:
    1. Currently, the variations form for Human Medicinal Products is undergoing closed User Acceptance Testing (UAT) with members of the DADI Subject Matter Expert Group, which is expected to conclude in August 2022. The external UAT has been rescheduled from Q2 2022 to September 2022.
    2. Afterward, there will be external User Acceptance Testing involving a larger group of still limited testers representing heterogeneous stakeholders. The product team has rescheduled the external UAT from Q2 2022 to September 2022. More information about the UAT organization is to be published in June.

The goal of the UAT is to guarantee the quality of the system, not to provide early access for an unlimited quantity of users.

  1. The data cleansing timeline has been deleted since it is not considered a precondition.
  2. The date for launch is still set to October 2022, and for mandatory use in April 2023, too. The target release dates, therefore, remain unmodified.

For further information concerning data cleansing of SPOR data sources, check the eSubmission Webpage or the updated DADI Timeline:



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