Yes, Virginia, you ARE ready for eCTD!
Yes, Virginia, you ARE ready for eCTD!
It is my pleasure to introduce you to one of our “newest” members of the McCormick LifeScience team! Nannette Hayes, RAC, has 12 years of Regulatory experience and holds her RAC certification. She has operations and strategy experience working on trials conducted in the US and OUS (Canada, UK, Bulgaria, Czech Republic, Australia, Brazil, Colombia, Argentina, etc.) in Phases 1-3 with a special interest in working with controlled substances in clinical studies. Nannette also has experience with the preparation of several NDAs and post-market requirements. Always a team player, Nannette possesses a great work ethic, sense of humor and dynamic personality!
Let it roll Nannette!
Remember back in the day when you had to painstakingly print out volumes and volumes of paper for any IND, NDA, BLA or Master File submission to the FDA? That feeling of “Doh!” when you were using the rubber finger to QC and you realized that there was a blank page forcing you to insert a printed page stating “this page intentionally left blank”? The worst, right?! Well, times are changing! Beginning May 5, 2017, NDA, ANDA, BLA and Master Files submission types must be submitted in eCTD format. As of May 5, 2018, Commercial IND submissions must be submitted in eCTD format.
Let’s think back to a simpler time. In 1990, the International Conference on Harmonization (ICH) organized to create a consistent filing format across the US, EU and Japan. Hence the Common Technical Document (CTD) and electronic CTD (eCTD) were born. Organized into five modules, the eCTD groups content together so it’s easier for Regulators to find the appropriate content and easier for Sponsor as they now write one set of documentation for a multi-region submission.
Here is a breakdown: Module 1 is region specific (cover letter, forms, labeling, etc…), Modules 2, 3, 4 and 5 are intended to be common for all regions. Modules are as follows:
- Module 1 – Region specific
- Module 2 – Summaries (basically a corresponding summary for each non-regional Module (3,4, &5),
- Module 3 – Chemistry, Manufacturing & Controls (as we like to call it, CMC)
- Module 4 – Nonclinical
- Module 5 – Clinical (all data)
Now, instead of flipping through volumes of paper to identify where to start, a Regulator can click directly in the appropriate module and get to work reviewing. Fewer questions about where Sponsor’s information is located means more Regulator time in his/her chair reviewing your application. That sounds like a win, right?
Although filing in eCTD format may sound cumbersome and like a whole lot of extra work to some Sponsors, eCTD has become the preferred method for submissions OUS and now in the US. In fact, in July of 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the format of choice for NDAs submitted to the FDA. The information required content wise for any submission type is the same in eCTD as it was in the old school paper format, it’s just better organized so information is now easier to find & more streamlined.
If you’re planning to submit a new NDA, ANDA, BLA or Master Files between now and May 2017, seriously consider submitting your dossier in eCTD (you’ll likely have to convert down the line anyway). After May 2017, paper will no longer be accepted. Follow a few easy steps to make your informed decision:
- Take some time to pull together a content map using FDA’s eCTD Table of Contents to see what documents you’d need in your eCTD submission. Then generate a working list to track documents requiring authoring, PDFing, publishing.
The Comprehensive Table of Contents Headings and Hierarchy
- Get your internal documentation in order and read up on the pdf and Electronic Requirements. Look into templates or working with a consultant/contractor with these skills and abilities.
Electronic Common Technical Document (eCTD)
eCTD TECHNICAL CONFORMANCE GUIDE
- Decide if you want to grow a Regulatory Operations group internally or reach out to eCTD publishing vendors for submission capabilities.
- Reach out to former colleagues, consultants you know or check into RAPS, DIA etc… to get a feel for what other folks are doing. You may be surprised by how few you come across still submitting paper.
If you have a current application and you’re looking to convert from a paper application to eCTD, reach out to your current Regulatory Project Manager (RPM) at FDA to let him or her know that your company plans to convert to eCTD. Pick a submission that won’t be too painful to convert, such as an annual report and the eCTD process will start from that submission forward. Remember, once you convert an application to eCTD, there is no going back, so all subsequent amendments or supplements have to be eCTD.
Once your company has made the decision to convert, get amped! Technology has allowed us to check in on our kids at daycare with webcams, chat with a stranger across the world via social media or track our spouse’s mileage using an app on a cell phone (wink, wink!). If we can do all that using technology, why not use technology to bring medications to the people faster? Remember, a more streamlined dossier = a faster review = your drug reaching the masses in less time!
- Think about the benefit of having all the information a Regulator needs at his/her fingertips and the time you’ll save during review.
- Take internal stock of your documentation and make an informed decision about when you want to convert to eCTD, now may be the time.
- If you don’t know what to do, reach out! Call upon consultants (Ahem…McCormick!) and assess the overall cost/benefit.
- Focus on your goal! Drug approval! Now is the time…convert!