The task of the eSubmissions project is to implement electronic submission of information in support of marketing authorisation applications by applicants. There are two stages:
- The definition of Exchange Standards that govern the structure and format in which information may be submitted electronically; and
- The design and implementation of systems that enable the European Medicines Agency (EMA) and National Competent Authorities (NCAs) to receive, validate, process, store and review such submissions in a routine manner.
The Telematics Implementation Group for electronic submission and ICH Implementation (TIGes) was set up in June 2000 by the Telematics Steering Committee (TSC) as part of a structure for the management of European IT projects in the pharmaceuticals regulatory area endorsed by the Pharmaceutical Committee. The TIGes was replaced by the eSubmission Change Management Board (CMB) in May 2014 following the overhaul of the EU Telematics Governance Structure. The eSubmission CMB changed its name in June 2018 to eSubmission expert group to better reflect its current status, and tasks.
The eSubmission expert group is responsible for:
- Processing drafts and adopting new, and updated harmonised guidance, eCTD and VNeeS specifications, validation criteria, and other relevant eSubmission documents, and planning for activities related to business implementation.
- Liaising between different key user groups, business groups, and with stakeholders.
- Initiating or providing input to development projects within the eSubmission area.
- Observing changes in the business, legislative and standard landscape of the eSubmission domain to keep Telematics systems and related documents up to date in this respect.
- Taking overall ownership of the implementation roadmap for related systems.
The eSubmission expert group meetings are held via teleconference and hosted by the European Medicines Agency (EMA).
The eSubmission expert group has of the following key user groups with representatives from NCAs, EMA and industry associations:
- Human Harmonisation Group
- Veterinary Harmonisation Group
- Electronic application form (eAF) / Common European Single Submission Portal (CESSP) Group
- Common Repository Working Group
- eCTD v.4.0 Working Group
- PSUR Repository Working Group
- Gateway v.3 Working Group
Documents published by the eSubmission expert group can be found here
Terms of Reference
- The updated agreed Terms of Reference can be found here
For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. |
