Swissmedic

News Roundup Part 1: Agency News

Today’s post is a round-up of recent eSubmission-related news from the agencies, based on posts from my twitter account, www.twitter.com/kathie_clark.  Next time, a roundup of articles and conferences. The regulatory authorities haven’t put out much in the way of major updates recently, but there have been some updates worth noting: ICH issued a new valid-values.xml for study tagging files see… Read more →

Agency News, Documents and Presentations (Recent eCTD and eSubmissions News Part 2)

As promised, here is an expanded list of posts published recently on my twitter account, this time related to agency news: CMD(h) issued a new Best Practice Guide on the use of eCTD in the MRP/DCP. Dr Martin Moxham of iRegulatory provided an excellent review of the updated CMDh best practice guide. CMDh also posted Contact E-Mail Addresses For Submission… Read more →

EMEA and SwissMedic News

EMEA has released new versions of their electronic Application Forms (eAF) as part of Volume 2B – Presentation and content of the dossier.  All three forms (for new applications, variations and renewals) have been posted.  Updates are due to changes in the Data Exchange Standard Definitions released July 2009.  Changes are significant, so if you have done any custom development… Read more →

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 →