15.04.2015

National implementation of EU eSubmission roadmap - information from UK MHRA and CZ SUKL

The EU eSubmission roadmap has already been adopted in November 2014 (see link here). One major objective of the eSubmission roadmap is to switch from paper to electronic format for drug regulatory dossiers and to harmonize the electronic formats that are currently in use - or in other words - to get rid of paper and NeeS format.

As a first milestone, the submission of new marketing authorization applications in the Decentralized Procedure must be done using the eCTD format from 1st of July 2015 onwards. (Background: the majority of new initial DCP applications are already submitted in eCTD format ~ 90% depending on the involved RMS and CMS)

In line with EU eSubmission roadmap the UK MHRA and the CZ SUKL have released national statements to underline the milestones as set forth in the roadmap.

Similar statements from further national drug regulatory agencies can be expected.

[Sources: MHRA, SUKL, EMA]

 

 

 

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