| FDA: oltre 30,000 eCTD |
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Source: Internet - eCTDBlog.com 07 July 2008 One of the more interesting tidbits listed from the DIA Annual -- a rough breakdown of how many eCTDs the FDA is processing. I'm really impressed by these numbers.
So, where are the areas of expansion for eCTD? Europe is promising to enable eCTD as a viable submissions option across the EU in 2009, although individual nations may have legislation that makes complete abandon of an eCTD difficult. The EMEA is leading by example, requiring that all Centralised Procedures be submitted as eCTDs. Canada is still in a slow adoption mode, and Japan, while a growth area for drug submissions, have made their standard deviate enough from the other areas that there seems to be a lag in eCTD adoption there. Australia is rumored to be working on their Module 1 guidance. Expansion beyond ICH regions would be a nice precedent towards global adoption. |
