Swissmedic Publishes M1 eCTD Specification, Validation Criteria

SwissMedic has issued a package of eCTD related specifications Swiss M1 Specification for eCTD Other Documents (DTD/MOD) Swiss eCTD Validation Criteria I have only done a cursory analysis as my day job is a bit overwhelming at the moment. The specification differs notably from the EMEA spec in several areas: SwissMedic has issued their own file and folder naming conventions for M1 as of course their M1 contents differ from EMEA Module...

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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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Sweden, Spain and Hungary Post Electronic Submission Specifications

As the EU authorities continue their progress towards welcoming eSubmissions, information continues to surface on their web sites and elsewhere. The Swedish National Authority (MPA) has updated their web site with new eSubmission information – see Electronic submissions to the MPA. The MPA maintains a dedicated email address (eSubmissions@mpa.se) for general questions on electronic submissions. They also provide guidance on...

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