Greetings faithful readers, and I do mean faithful if you have been reading the blog consistently despite the lack of regular updates. I've been quite busy with Real Life and Day Job and sadly have not been keeping up with you out here on the Web. A lot has changed since last I wrote you, but I trust that the wonderful world of eSubmissions has been keeping you quite busy. A quick recap of things that have happened since we last spoke:
- SwissMedic has revised their eCTD spec again (yes, already): CH 1.1 eCTD
- The Japanese agency has suggested that sponsors include additional sections in the JP M1 (a new section per each "additive" or excipient)
- ICH has updated the STF Valid Values specification (v3.0)...
- ...which is clearly intended to support the updated FDA guidance on organizing datasets (basically putting tabulations into two folders -- one for sdtm datasets, one for "legacy" non-sdtm dataset -- take a look at the mockup on page 8).
- The rumor is that the timeline for implementation will be next year, coinciding with an FDA review system upgrade, but that has not been confirmed on the agency's website as of this writing. The may be an FDA M1 specification update in the works around that time, but this is still speculation.
- Croatia put out an eCTD specification. Finding this is difficult since vendor press releases seem to be easier to get at than the specification itself.
- RPS (the eCTD successor) has had some activity amongst the testing team, but is still a bit away from a workable specification for industry...or that's some people's opinion. :)
Good luck with the end of year rush, and be kind to your sofware vendors!
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