Top 10 Validation Errors for Health Canada

  The AAPS Workshop on Strategic Management of CMC Dossiers in the eCTD Format: What CMC Professionals Need to Know Now! was held March 9-11, 2009. There were some great presentations, and best of all they are publically available. The agenda contains links to the presentations. All the presentations were good but some of the highlights for me appear below. There’s great information on Japan and Health Canada that has been rather...

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ICH Presentation Includes Latest on eCTD, RPS Standards

This is not really new news, but ICH has posted the short presentation “Update on the eCTD” from the November meeting on their website.  This presentation was given by Joe Cipollina. The key elements of the presentation include: ICH eCTD requirements will be submitted through the SDO Joint Initiative into the HL7 Regulated Product Submission (RPS) standard, Release 2 RPS R2 is currently under development to provide a...

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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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Notes on RPS Version 2 Working Group Meeting

An RPS2 Working Group meeting was held in Vancouver the week of September 15. The working group discussed a number of business scenarios including: Two Way Communication – Pre-Submission Correspondence Submission Activities – Request Submission Number Submission Activities – Meeting Request and Responses Notification of Decision or Action Request/Response for Additional information during a review cycle Follow-up/Postmarket...

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ICH Publishes Updates to eCTD Specification

ICH has published a new eCTD specification (version 3.2.2) and STF specification (v2.6.1), as promised some time ago. This was done with little fanfare – the announcement and links to the documents can be seen at: eCTD News For those of you who monitor What’s New on the ICH website? – the updates did not merit a mention there. The changes resulted from a June meeting, the documents are dated July 2008 and were...

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