In March 2017, version 2.0 of the EU eSubmission Roadmap has been published and states that eCTD will become the only accepted format for Human Medicinal Product registrations in Europe.
In March 2017, version 2.0 of the eSubmission Roadmap has been published.
The eSubmission Roadmap is used as a high level strategic plan for business and technology change, typically operating across multiple disciplines over several years in Europe.
It is a tool to align the plans of target groups and help National Competent Authorities (NCAs), EMA and pharmaceutical industry.
The eSubmission Roadmap states that eCTD (electronic Common Technical Document) will become the only accepted format for Human Medicinal Product registrations in Europe.
As reflected in the visual representation of the roadmap, in 2017 eCTD is already mandatory for CP, new DCPs and MRPs.
However from January 2018, all MRP submissions (initial and post authorization) have to be in eCTD format. From July 2018, all new initial MAA for national applications will have to be in eCTD.
From January 2019, all activities for all procedure types will have to go in eCTD format (CP, DCP, MRP and NP; initial and maintenance activities).
For Industry it means that companies have to transform legacy dossiers from non-eCTD format (NeeS and paper) into eCTD.
Even though a baseline is not mandatory, from a company perspective it is highly recommended.
However, a final decision depends on the format of the dossier (NtA or CTD), number of life cycle activities, etc.
In addition, global companies with national registrations, have to think about a solution for the eCTD publishing of national registrations.
This eCTD publishing can be done centrally, locally or could be outsourced to a third party.
Last but not least a company that doesn´t have yet capabilities of eCTD publishing, can consider to implement an eCTD publishing tool and/or outsource.
This decision depends on the size of the company, portfolio and number of activities.
In the end, the mandatory use of eCTD will result in transforming existing working methods and processes.
Asphalion provides services for:
- eCTD Publishing
Asphalion has over 10 years of experience with eCTD and support all EU procedure types (CP, MRP/DCP and NP).
We support a large number of clients that completely outsource the eCTD publishing activities to us.
We can publish with our own implemented tool, or with remote access to the Client´s tool.
- Implementation of IT publishing tools
Asphalion has implemented eSubmission tools in over 50 clients.
This service includes: installation, training, validation and 1st level support for the daily use of the tool.
In addition, we can support with the review of processes and implementation.
If you are interested in any support, please contact us at eCTD@asphalion.com