Australia and the eCTD

So, by now all of us are probably familiar that the main areas accepting eCTD are the US, EU, Japan and Canada.  As CTD takes hold, some other areas are talking about initiating eCTD projects of their own.

Chief amongst them appears to be Australia.

According to the Therapeutic Goods Administration (TGA) website, an eCTD project has been initiated that will:

The TGA project will:

• develop a specification for the Australian Module 1 (Region Specific information) of the eCTD,
• identify the TGA requirements for viewing/reviewing software and initiate procurement of that software,
• identify internal technical requisites and integration with other business systems,
• identify the changes to our business rules necessary for processing eCTDs, and
• produce Guidance for Industry.

The TGA have already defined their Module 1 standard for paper CTD, so it probably serves as a good reference for how documents may be authored for any upcoming eCTD.  Although no specific timeframes have been released, many speculate that eCTD will be moving forward in Australia in 2009.

Interesting eCTD Article, Translated from Spanish Courtesty of Google

When browsing the recent eCTD headlines, I found this Spanish language interview with Juan Ramon Gutierrez of IBM, talking about the trends of electronic review to the Spanish health authority, the AEMPS. 

It was a good read, and I was impressed with the accuracy of the translation via Google translate.

Google Translate (English)

Original Article (Spanish)

Regulatory Tracking and Publishing

Greetings, faithful eCTD readers.  Sorry for the delay in posting but as many of you know, the vacation season was upon us!  Although the break was nice, my inbox didn't stop accepting messages and I'm presently digging my way back out.

In any event, as regulatory groups start analyzing their needs regulatory tracking systems are emerging as a component that can assist with regulatory affairs planning and commitment tracking.  Particularly in global organizations where local operations are handled by remote branches that are note well connected to headquarters, there is not always a good understanding across sites of details such as submission status, and in some cases, local brand name.

As these systems become standardized, integration with publishing systems is a logical step.  The question -- which way does the integration work?

• Do tracking systems act as the staging area where submission details (and in the case of eCTDl, submission metadata) is planned, and then pushed to the publishing system as a stub or template publication, OR
• Do publishing system automatically recognize information that has been published, and simply reflect the actions taken by the publishing team?

Although both may be possible, ultimately this is a bit of a chicken and egg question -- which is the logical starting point of a submission?  The tracking system, or the publishing system?