The esubmissions project is concerned with implementing the submission of information in support of marketing authorisation applications by applicants electronically. 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.
TIGes is responsible for the development of Electronic Common Technical Document (eCTD) regional standards and their implementation. All concerned NCAs and the EMA are represented and a relevant expert of an NCA chairs the group.
TIGes works in close collaboration with the European delegation of the ICH M2 Expert Working Group responsible for the ICH eCTD Specification.
TIGes meetings are held 4 times a year at the European Medicines Agency (EMA) in London. Industry representatives from European Federation of Pharmaceutical Industries and Associations (EFPIA), EuropaBio and European Generic Medicines Association (EGA) are invited to attend during the second day of the meeting (TIGes Joint meeting).
The following projects are ongoing at present:
- Implementation of the Electronic Common Technical Document (“eCTD”);
- European Union Review System ( EURS)
- Implementation of the Product Information Management system (PIM)
- Harmonisation of eSubmission guidance in the EU; and
- eCTD Roadmap
The TIGes consists of the following sub-groups:
Change Control Process
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