The GPS of Regulatory Submissions

GPS…how did we EVER live without it?!?! January of 2012…it’s in our cars, it’s on our phones…and when we don’t have it, we feel lost (pun intended!) and anxious! Do you have a spouse or a friend who’s stubborn and won’t stop to ask for directions?!?! My father, (love him to death by the way), has always been last to stop and ask for directions. My brother, Scott, and my mother will back me up on that one! He’ll be sure to find his way there…it just may take a while longer, require a few four-letter words, and result in higher blood pressure! Thankfully, those days are over for most of us as we have grown reliant on our GPS systems!

7Driving without GPS (now that we have access to it) is like writing an Investigational New Drug application (IND) or New Drug Application (NDA) without using the user-friendly Common Technical Document (CTD) format. It’s stressful, unsystematic and takes forever! The International Conference on Harmonisation (ICH http://www.ich.org/) has very kindly devised this universal format for all of us to take advantage of and make our lives more efficient and less stressful! When you sit down to write a multi-volume submission containing an insane amount of data and information, doesn’t it make sense to follow a “map” if there’s one to follow? Much more attractive to me than starting with a blank page! Don’t be stubborn like your father or wife or friend who won’t stop and ask for driving directions! Take advantage of the resources provided to you! This could ultimately prevent you from getting that next gray hair for one more year……<<wink, wink>>

OK, so really, why follow the CTD format when writing Regulatory submissions? Here’s a response from someone (me!) who’s done it both ways………

  • It’s easier, it makes sense, and it saves us time and aggravation! (This alone should sell you on the idea!)
  • You will make the Regulatory Agency happy…isn’t that our goal here!? To make them (the FDA for example!) happy and get our products approved for market to help those suffering from medical conditions? From a review perspective, the information is organized in a very user-friendly way, therefore making our reviewer’s lives much easier! Ultimately resulting in a happy Regulatory Agency. What’s better than that? (ok, warm chocolate chip cookies, but…)
  • This format is accepted by various international Regulatory agencies. Therefore, if you start in this format and later want your product approved for market in other countries beyond the U.S., (i.e. Europe, Japan), you don’t have to re-write your application! As an example…if you completed an IND in the U.S. for the FDA and you decide you want to initiate human clinical trials in Europe, the CTA (Clinical Trial Application) can also be in the CTD format. You’re 90% of the way there! Same goes for an NDA in the U.S…..easily converted to a MAA (Marketing Authorization Application) in Europe! Fancy that! 🙂

So now you’re wondering, Where to start? How to start?

All you need is 2 things:

1) TEMPLATES! No, you don’t need to start from a blank Word document! How about a populated template package containing all of the CTD sections with proper granularity and headings, as well as guidelines for authors included in each section? Sound too good to be true? Call us…we’ll provide you with a customized (to your company/product) and ICH compliant template package! Don’t want to purchase from us? Try these vendor’s templates:
—-Liquent: http://www.liquent.com/smartdesk_authoring.html
—-Octagon: http://www.octagonresearch.com/starting-point.html

2) ICH Guidelines for CTD format! A comprehensive instruction package and detailed layout for all Modules of the CTD. If you are involved in Regulatory submission writing, this lovely “packet” will become your “BFF” (that’s Best Friend Forever for those of you who don’t have a “tween” speaking text language).
—-Click here to download the ICH guidelines for CTD format. Yes, it’s free! http://www.ich.org/products/ctd.html

Not convinced yet?!?! See Toto’s Tips below…maybe he can help. I hope you try it out. Let me know what you think. It may take a little getting used to, but with time, I guarantee you’ll like it and come running back to me with arms flailing, saying, “Kelsey…you were right, you were right!” (something I’ve trained my husband to do quite often by the way)

Toto's Tips

  1. Use the CTD format for other documents in addition to clinical trial and marketing applications. If you use the same format for your investigator brochures (IB), annual reports (AR), internal nonclinical study reports etc., you will save yourselves a lot of time with organizing and typing information. This will allow the information to be much more transferrable across documents via our favorite writing tool known as, “cut and paste!”
  2. Are you in the pre-IND phase or pre-NDA phase? No matter your answer…start using the CTD format for your product(s) as early on in the process as you can. It’s never too early to start adopting the format! Although CTD format is not required until the NDA electronic submission (e-CTD), if you start early (pre-IND phase), you will save yourself a ton of headache, time, and money when it comes time to preparing your NDA. Kinda like stopping to ask for directions before you’ve driven around aimlessly for 2 hours!