When I think of style, the first thing that comes to mind is fashion.  Being stylish is to wear clothes that are becoming to your size and shape (you look good!)  and are functional, that is, they keep you warm in winter and cool in summer.  But, style goes beyond clothing or other things like interior design, automobiles, architecture, etc. 

In the world of regulatory writing, how your document presents and how it performs are critically important if it is to meet the rigorous standards of electronic submissions to worldwide regulatory agencies. 

Three Tenets of Style

Basically, there are 3 important tenets of style when it comes to regulatory writing:

follow a style guide,

have authors trained in the use of Microsoft Word and its associated templates, and

use well-designed templates that contain built-in styles. 

In this post, I will concentrate on the importance of well-designed templates and their subsequent impact on an electronic submission.  Style guides and training will be covered in a future post.  Stay tuned! 

Because IMPACT writes and publishes so many CSRs, we get a lot of sponsors asking us questions about how CSRs should be published.  This tells me that there’s a lot of confusion about CSR requirements and, in my opinion, some of that confusion stems from ICH E3.  I thought I would use Ilana Dew’s recent blog post about ICH E3 as a jumping-off point from which to talk about what that document means to us as publishers. 

In her post, Ilana discussed the medical writer’s perspective on transparency and flexibility in E3.  I’m really glad she brought up flexibility because as a publisher advising sponsors about CSR publishing, the first thing I tell them is that ICH E3 is a guideline, not a guidance. 

In fact, in 2012 the ICH E3 working group even released a Q&A document to state this very clearly because sponsors were asking about it.  Thus, we do our best to comply with the spirit of E3 while also meeting the needs of electronic submissions. 

Over the years I’ve heard a whole bunch of misconceptions and misunderstandings about making the change from paper submissions to eCTD.  Since the deadline to convert NDAs, ANDAs, and BLAs has recently passed (May 5th, 2017) and the deadline for INDs and DMFs is now a little less than a year away (May 5th, 2018) I thought I’d address some of them. 

People who work in Regulatory Affairs, and especially those in Regulatory Operations, are well aware of the fact that it is less than a month before eCTD submissions will become mandatory.  Starting on May 5th, all NDAs, ANDAs, and BLAs that are submitted to the FDA must be filed in eCTD format. 

Many companies have already transitioned to eCTD submissions.  However, for those companies that have not transitioned to eCTD submissions, we have some things to keep in mind regarding the requirement.