Transitioning from Paper to eCTD
Sep07

Transitioning from Paper to eCTD

The most frequently asked question related to the conversion from paper to eCTD is, “Are we required to resubmit everything we’ve previously submitted in paper to the ‘new’ eCTD application?” Thankfully, FDA does not require you to resubmit information that was previously submitted in paper. However, you may find it useful to occasionally “backfill” your eCTD application by resubmitting previously submitted information for the convenience of the FDA reviewers.

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eCTD Publishing Best Practices
Mar09

eCTD Publishing Best Practices

People seeking advice on eCTD publishing best practices usually fall into one of two groups: (1) Sponsors who are new to eCTD, for example, medical writers or project managers (2) eCTD publishers. The first group is usually interested in specific actions they can take to make their specific submission a success, while the latter group is more interested in strategic ideas on how to make their processes work better for all submissions.

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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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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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Europe Working to Establish Electronic Submission Gateway

I caught up with Tim Buxton of EMEA at the DIA meeting in June. Tim’s big news is that EMEA’s Electronic gateway will be operational shortly, although he could not release a date. The gateway has already been tested with a variety of submissions. Tim stressed that the EMEA is serious about enforcing the use of eCTD and no longer accepting NeeS as of the published 1 January 2010 deadline. He mentioned that forward-looking companies are...

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