A Tribute to the CTD Pyramid

I would like to confess my undying love, and total respect for the CTD pyramid.

Oh sure, at first I thought it was an overused bit of clipart, sort of like the thinking man with question mark above his head or perhaps a rotating globe. I however, was mistaken.

True, the CTD pyramid has to some become something that does not explain a whole lot...but it has grown on me for the following reasons:

• It roughly explains the typical Regulatory Authority review process. In all this talk of study tagging files, node extensions, xlink hrefs, etc. etc. it brings you back to what a truly beautiful idea the CTD format is -- a roughly consistent approach to submitting eCTD applications that you can count in many of the biggest markets for life sciences: the US, European Union (and many non-EU European nations such as Switzerland and Norway), Canada, South Africa, Australia, Japan, and to a lesser extent ASEAN nations, Russia and some Latin American countries. Historically this is such a huge step in the right direction and a big effort saver for life sciences orgs. Now, you roughly have an idea not only on how to format these submissions, but additionally how they will use the section to navigate: starting at the regional M1 to get legal and regional requirements, etc. answered, moving on the M2, for the high level executive summary in the 2.2 Introduction, moving onto the high level overviews in 2.3, 2.4, and 2.5 and more detailed summaries in 2.6 and 2.7. and then branching out (usually via paper based cross-references or PDF hyperlinks) into the details of M3, M4, and M5. It's not accident that the subsection of these summaries in M2 (2.3, 2.4 and 2.5) correspond the Module number (M3, M4, M5) of the details the refer to. Oftentimes people complain about the regional differences (or non-harmonies) but the benefit of a roughly defined review process is worth the price of entry by itself.
• When you stroll late into a session at a DIA, RAPS, or other regulatory conference and see this beauty on a PowerPoint slide, you know you're in the right place. I can't be the only person who has done this. C'mon conferences are supposed to be half networking opportunities anyway!
• It invokes the mystical powers of the pyramids. Seriously, this thing looks like a triangle to me but everyone still calls it a "Pyramid". I think there's something more to this.