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 has taken over the tasks of the TIGes and it’s subgroups.
The eSubmission CMB is responsible for the development of Electronic Common Technical Document (eCTD) regional standards and their implementation. According to the new telematics governance structure decision, number of concerned NCAs and the EMA are represented. The Chair and the Co-Chair of the group are from the EMA and NCA respectively.
eSubmission CMB works in close collaboration with the European delegation of the ICH M8 Expert Working Group responsible for the ICH eCTD Specification as well as the ICH M2 Expert Working Group responsible of Electronic Standards for the Transfer of Regulatory Information.
eSubmission CMB meetings are held via teleconference and are hosted by the European Medicines Agency (EMA). The CMB meets once a year for a face to face meeting at the EMA in London. Industry representatives from European Federation of Pharmaceutical Industries and Associations (EFPIA), EuropaBio and European Generic Medicines Association (EGA) participate in the work of the eSubmission CMB via memberships in the CMB Maintenance Groups as relevant.
The eSubmission CMB has of the following Maintenance Groups:
- Harmonisation Maintenance Group - Human
- Electronic Application Form (eAF) Maintenance Group
- Common Repository Maintenance Group
- eCTD Maintenace Group
- Harmonisation Maintenance Group - VET
The eSubmission CMB/TIGes documentation can be found here
Change Control Process