We are upon uncertain times within the Regulatory world. The United States Food and Drug Administration (FDA) has already started moving toward making eCTD mandatory for all submissions by May of 2018.
By Jason Grube, EXTEDO
In below sections, I will discussion some topics to take into consideration before submitting to the FDA.
So what is eCTD you may ask? The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. By moving toward eCTD format, agencies are better able to harmonize, share and search through information in a more structured manner. This also has an additional benefit of cutting down the times of review and ultimately getting products to the patients faster.
Now your company wants to adopt eCTD, but how do you do it? Fortunately, there is more than one option for your company. Many companies prefer to keep everything in-house and purchase a software tool, which allows the creation of eCTD submissions. Other companies elect to outsource their submissions to other companies. In either case both are acceptable, the FDA just needs the submission to be in eCTD format and compliant with their validation criteria.
The days of shipping boxes and boxes of binders are over. With the move to eCTD, paper submissions are now outdated. So you may now ask yourself, how does my company get our submissions to the FDA? The FDA now requires companies to use their Electronic Submissions Gateway, commonly known as the FDA ESG. In order for companies to access and use the FDA ESG, they must first create an ESG Account. The FDA has provided systematic instructions on their website on how to set up this Account. Most people do not realize how complex these instructions are and that the entire end-to-end setup can take up to a month based on FDA responses. Companies may also elect to have consultancy companies with existing ESG Accounts submit their submissions through the ESG on behalf of your company.
Things to know before you send your submission through the ESG are as follows. First, is what Center is your submission going in the FDA. The FDA has multiple Centers that submissions can be routed to, whether it is CDER, CBER, or OTC. Selecting the wrong Center can delay the submission from getting to the reviewer, or even result in the submission being rejected. Secondly, you must always have the correct forms included in your submissions. The fillable forms that need to be included can be downloaded off the FDA website for you to fill out. The ESG uses these fillable forms to route your submission to the correct Center locations. The forms need to be filled out with information that is consistent with the contents of your submission and once completed it must be electronically signed. However, if your company does not have an electronic signature process in place, you can submit the filled out electronic form without an electronic signature along with a printed scanned wet ink version of the form.
So your company now knows how they are creating eCTD submissions and how to deliver those submissions to the FDA; what else should your company take into consideration before submitting? Most importantly, your company is responsible for all the content that goes into your submissions. If you are unsure of what needs to be included in each of your submissions, you should contact your Project Manager (PM) at the FDA.
Finally, your company has all the content for an eCTD submission. You have filled out and included your forms into the submission. Your company knows how they are delivering it to the FDA. Does your company know if your submission is compliant with the FDA standards? In the next article, I will discuss some of the things the FDA is looking for to ensure submissions are compliant as well as some EXTEDO recommendations.