The European Medicines Agency (EMEA) announced plans to implement the electronic-only submission of information in support of marketing authorisation applicants in the Centralised Procedure.
The EMEA implementation strategy, which applies to all applicants (new and existing) and all types of submissions in the context of the Centralised Procedure.
- From 1 July 2008, the EMEA accepts electronic – only submissions, either in eCTD (electronic Common Technical Document) format or NEES (non-eCTD electronic submissions) format, with no additional requirement for paper copies.
- From 1 January 2009, the EMEA strongly recommends electronic-only submissions, either in eCTD or NEES format. Paper is an exception to the general e-format recommended for any applicants.
- From 1 July 2009, the EMEA will strongly recommend e-CTD format electronic – only submissions. Paper and other electronic formats will be an exception to the general e-CTD format recommended for any applicants.
- From 1 January 2010, the EMEA will require e-CTD format electronic – only submissions.
In addition, according to ICH requirements, all regulatory agencies from January 2010 are obliged to be capable of accepting dossiers submitted in all community procedures (MRP, DCP and national) in eCTD and/or NEES (non-eCTD electronic submissions) formats. It is highly probable that in near future only dossiers in eCTD format be accepted by regulatory agencies.
