Updates on the HMA eSubmission Roadmap

The eSubmission Roadmap v2.2 has recently been updated by the HMA. The purpose of the roadmap is to provide a high level strategic plan for business and technology changes over several years, and is meant to help NCAs, EMA and pharmaceutical industry prepare themselves for the forthcoming changes. Many of the adjustments are likely due to the EMA’s relocation.

Compared to the version 2.1 of the roadmap, the most important changes are

  • removal of the timelines for eCTD 4.0
  • postponed CESP dataset module for new MAAs and for other applications
  • postponed date for preparation of the mandatory use of an EU single submission portal, and a stepwise implementation of a common telematics service desk
eSubmission_Roadmap

HMA eSubmission Roadmap v2.2 (June 2019)

eCTD 4.0

In the eSubmission roadmap v2.1 it was originally planned that eCTD 4.0 should be used for human CPs starting from Q2 of 2020, and starting from Q2 of 2021, it would have been mandated for human MRP and DCP as well. These deadlines have now been removed to allow for the planning and preparation of a stepwise implementation.

We at LORENZ are prepared for the upcoming challenges of eCTD 4.0 implementation and are currently advising our agency and industry customers on viable paths forward.

eGateway CESP

The CESP dataset module to be used for eAFs for new MAAs has been postponed from mid-2019 to Q2 2020. It will become mandatory 6 months after the delivery. In addition, for other applications such as renewals and variations, the dataset module is now planned to be delivered by the end of 2021 (previously planned for 2020) and then becomes mandatory 6 months later.

Furthermore, the date for preparation of mandatory use of an EU single submission portal has been postponed from 2021 to mid-2022, and also includes a stepwise implementation of a common telematics service desk.

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