Swissmedic Outlines Early eCTD Specifications

SwissMedic has added new information to its website on their plan for accepting eCTDs. Some key points: Swissmedic intends to accept authorisation applications in the eCTD format, i.e. in electronic form and with no paper documentation. In doing so, Swissmedic aligns itself with the EMEA road map for implementing eSubmissions in the EU Member States (Centralised procedure). Electronic submissions are to be accepted in eCTD format only...

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Regulators Discuss Best Practices for EMA eCTD Submissions

EMEA-EFPIA Information Day 2009, which was held on 24 February 2009 in London, included several interesting presentations about eCTD and NeeS. Claire Holmes of EMEA presented on eCTD/Non eCTD electronic Submission (Nees): impact on the centralised procedure. Ms. Holmes explained the background of the recent announcement about mandatory eCTD: based on legal advice from EMEA, instruction was given that although eSubmissions cannot be...

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NeeS No Longer Accepted for Centralised Procedure

Sounds like EMEA stayed busy through the holiday season as they posted four new or updated guidance documents at the end of December. Most significantly, EMEA implementation of electronic-only submissions and mandatory eCTD submissions in the centralised procedure: Statement of Intent tells us: “From 1 January 2010, the EMEA will mandate the use of the eCTD format for all electronic-only submissions for all applications (new and...

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