An Aggregation of Recent eCTD News, Part II

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 Of Electronic Response Documents During Mutual Recognition & Decentralised...

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The Latest EU eCTD Submission Guidance

There has been a lot going on at the various European agencies in the last few months. This week, we look at some of the announcments and guidance documents that have been issued across Europe recently. France Caroline AURICHE, Philippe DÜRR and Cécile LEVY from AFSSAPS spoke at EXL Pharma, presenting on Taking the plunge from paper into electronic-only in the EU – the 18-month feed-back experience of «paperlessland» in the...

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Pharma Industry Survey Addresses Document Management Systems, eCTD Adoption

Recently, I caught up with my old friend Steve Gens (of Gens and Associates Inc.) to talk with him about a very interesting global survey he just completed on “Benchmarks of Emerging Technologies and Approaches for Collaboration and Document Management” in the Pharma industry. The 2009 survey was completed in partnership with Steve Scribner of International Life Sciences Solutions, as a follow-up to their well-received 2007 survey....

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What’s Included in the New EU Module 1 Specification v1.4?

As promised, the EMEA released Version 1.4 of the EU Module 1 Specification on schedule in August. The new spec has some changes that will impact eCTD assembly, publishing, verification and viewing software tools. The EMEA has reached out to the vendor community to ensure that they are aware of the changes to ensure that they can modify their products in advance of the required implementation timeline. It’s worth reproducing that...

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Europe Reports on Progress of eSubmission Initiative

Rob de Haan, deputy director at MEB, spoke about the status of eCTD at MEB, and also presented a variety of EU statistics, many of them updates from the eCTD Implementation Survey Report published in December of 2008. MEB now has a full e-working environment (although they make almost no use of their eCTD viewer, for reasons Rob didn’t go into). eSubmissions (eCTD and NeeS) for human medicines are mandatory. Case managers and...

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