eSubmissions

Further guidance on eSubmissions can be found on the EMA website under eSubmission

  • Information related to the CESSP project is available on the CESSP eSubmission website and on the EMA website. (November 2016)

  • Technical validation of eCTD submissions for new MAAs in DCP - voluntary pilot
    The pilot phase ended on 31 December 2013.
    A more efficient process for the technical validation is currently being discussed. The objectives as set up in the EMRN eSubmission Roadmap will be taken into account. The draft Roadmap is published on the HMA CESP website  (http://cesp.hma.eu/Home).