EMEA

New EMEA M1 Spec (V1.4) in August; Other Agency News

EMEA has announced that they will be releasing a new M1 eCTD specification in early August.  EMEA will be releasing version 1.4, including a new DTD, implementation guide, transition guide, and validation guide.  According to Claire Holmes of EMEA, this new version will accommodate recent updates to guidance on variations. The new version will be recommended from January 2010, and… Read more →

SwissMedic issues M1 Guidance/Validation Criteria: EMEA NeeS for Vet Meds

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… Read more →

Warning: Some HAs not accepting PDFs other than 1.4

Recently, some sponsors have been reporting the rejection of eCTD sequences or NeeS containing PDFs of any version other than 1.4. The Swedish agency Medical Products Agency (MPA) states on their website on the page Electronic submissions to the MPA “The MPA will check eCTDs against the A criteria listed in the “EU eCTD Validation Criteria” v.2.0 (see link to… Read more →

Folder Structure for Submitting Word Documents

New Draft eCTD Guidance for EU: Analysis

A significant new guidance document, Guidance for Industry on Providing Regulatory Information in Electronic Format: eCTD electronic Submissions, has been posted on the EMEA eSubmissions website.  This document has been prepared by the eCTD Guidance Topic Group of the TIGes. It is largely based on Guidance for Industry on Providing Regulatory Information in Electronic Format: Non-eCTD electronic Submissions (NeeS) Version… Read more →

MLHW eCTD Submissions

Loads of Great Information from The AAPS Workshop on Strategic Management of CMC Dossiers in the eCTD Format: What CMC Professionals Need to Know Now!

*** Update: the links below, which had been working fine between when this was posted and today (May 18), appear to be no longer functional.  Possibly the AAPS had not meant them for public consumption; however, I have not been contacted by them so I don’t know this for sure.  Apologies that the links no longer work but they are… Read more →