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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EMEA Update on eCTD Implementation

Attending the DIA EU EDM Conference in December gave me a great opportunity to catch up on eCTD-related status and activities at various European agencies. We heard from a number of presenters representing EMEA (now just European Medicines Agency), the MEB, Swissmedic, and AGES PharmMed. Since the updates are fairly lengthy, today I’ll cover EMEA, and will address the other agencies in a future posting. Tim Buxton gave the update from...

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EMEA Electronic Application Forms, Swissmedic M1 Specification

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 around the eAF, you will need to make a number of updates....

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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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