Fifteen years after its release it may seem as though there’s not much you don’t know about the electronic common technical document (eCTD), but 2017 is a crunch year for electronic submissions and you need to be prepared.
By Jennifer Tucker, Regulatory Affairs Manager, Business Process Services, CSC
Beginning in May 2017, all marketing applications – new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologic license applications (BLAs) – must be submitted to the U.S. Food and Drug Administration (FDA) in the eCTD format. This requirement also extends to drug master files (DMFs). Just one year later in 2018, all commercial investigational new drug applications (INDs) will have to be submitted in eCTD as well.
When moving from paper to eCTD you really want to give yourself 6 to 12 months to prepare for your first submission to ensure it’s the best quality possible, which will speed up the FDA review process, minimize back-and-forth with the agency regarding submission content and quality, and ultimately improve your chances of approval during the first review cycle.
Here are five steps you should consider when transitioning to eCTD.
Step 1: Get out and get learning
Before you even attempt to prepare your eCTD submission, make sure you understand the eCTD requirements and structure. If you don’t have the resources and expertise in-house, you’ll want to seek out training opportunities offered by industry experts, working groups and regulatory service providers.
Even if you do have a team in place, it’s a good idea to bring in an external trainer to help you lay the groundwork, not only in terms of the requirements and structure but also to create a customized training experience that will help your company understand how its specific business needs will fit into the process.
Step 2: Know your capabilities and do your research
If you have questions about the eCTD filing strategy, especially if this is your first foray into eCTD, you’re moving from an IND to a marketing application or you’re unsure about how to interpret the eCTD guidance documents for your content, a regulatory affairs partner can help you with strategy planning. But first you want to know that the partner you select is right for your needs.
Start by developing a questionnaire to determine their track record, that they have all the services you’re looking for, such as global regulatory submissions experience, CDISC expertise, labeling support, extensive publishing track record, etc., and they can cater to your budget and address your specific business needs.
If you are going to manage your eCTD submissions in-house, you may need help selecting, implementing and validating appropriate tools. For example, it’s worth considering the validation and review tools used by FDA, because if you’re using the same tools as agency reviewers, you know your validations will reflect what they see so you won’t miss errors that the agency will catch.
An experienced regulatory affairs strategist can help work with cross-functional teams within your company to ensure that: IT systems are properly configured; appropriate access will be available to internal and external team members; and your solutions will produce content that meets technical standards required for submissions via FDA’s electronic submission gateway (ESG) and other agency portals.
Step 3: Assemble your team
At this point you need to assign a team leader and identify team members, including from partners and other stakeholders (R&D partners, contract research organizations, third-party vendors) who may need to be involved in the eCTD transition.
Your team needs to agree on the overall strategy and content for the initial eCTD submission and get senior management buy-in for all key activities, including how information will be disseminated throughout the team. Make sure everyone understands the process for document hand-offs, and how you will approach timelines, budget concerns and ensure senior management is informed throughout the process.
Step 4: Act on planning and strategy
Once you have a good strategy for making the transition, it’s time to sit down with your content and do a gap analysis against the eCTD specifications, table of contents and guidance documents. You need to ensure the source documents that will comprise your eCTD submission have the appropriate quality, granularity and publishing aspects (e.g., hyperlinks and bookmarks). Comparing your paper content to your ideal electronic state will help you avoid costly and time-consuming pre-submission rework.
Next you need to consider timelines. Take into consideration the review time needed for all stakeholders to ensure the final output is complete, accurate and meets agency specifications for e-submissions. You’ll also need to allow time for any rework based on findings during the review.
Other important considerations include engaging in formal meetings with the agency – if there is a chance you will need to arrange a formal discussion with FDA before providing your first eCTD submission. There are very specific timelines associated with requesting and arranging those meetings, so it’s important to factor those in since these can add a couple of months or more to the submission timeline.
Finally, you should send an email or set up a call with your FDA reviewer(s) or other agency point of contact to ask any outstanding questions about your filing strategy and the transition to eCTD. Since the FDA reviewers will be dealing with your submission and are more than willing to work with you, it’s in your interest to make sure you are prepared for any unforeseen hurdles that might slow your review time.
Step 5: Putting steps 1 to 4 into action
If you carefully and thoroughly manage steps 1 to 4, the final step – executing on the plans – should be straightforward and allow you to avoid the problems commonly encountered during a first foray into the eCTD format.
Learn more about how CSC’s regulatory affairs strategists can guide you through the transition to eCTD in our recent webinar with DIA.