Editor’s Note: This post is the first of three coinciding with GlobalSubmit’s 3-part Module 1 Education webinar series.
As we’ve stated previously, the FDA’s implementation of a new Module 1 is the “biggest change in the history of eCTD.”
What exactly did the Agency set out to accomplish when updating the specification?
In a word, efficiency. Albeit a term severely overused in a business context, efficiency is central to the story of the new M1 and is accomplished a variety of ways:
- More automated system processes
- Hierarchical organization scheme
- Improved Sponsor-Agency communication
The FDA’s goal to get safe and effective treatments to patient populations in a timely manner demands a reliable drug approval cycle. Changes to the Module 1 specification align to this goal.
New sections were added to the eCTD TOC to support Promotional Submissions to CDER OPDP, which can now be submitted through the ESG. Grouped Submissions, in turn, will allow a sponsor to apply a single sequence to potentially 100 or more products. Here we have the foremost example of a manual, repetitive process being improved upon in the new specification.
When an application is cross referenced or grouped, a list of hyperlinks to those applications will be available to FDA reviewers with a “single click.”
Overall, changes to the M1 specification allow for more automation. When a submission enters the ESG, information is fed into FDA tracking systems and the review tool. As an added bonus, system improvements will be leveraged for the transition to Regulated Product Submissions (RPS).
Submission forms, such as the 356h, will be better tagged and read by the system.
Organizing submissions in a hierarchical manner as opposed to a flat structure will help FDA reviewers identify all documentation tied to a regulatory activity, i.e., a decision.
The FDA added new attributes to the specification to help with organization. For example, post-marketing requirements and commitments were added to Submission type. Submission sub-type (ex: pre-submission) is new altogether.
Sequence number and related sequence were not done away with – the FDA has merely modified how the information is collected.
Submission type has replaced related sequence and submission sub-type replaces sequence number. A new submission type indicates the first sequence belonging to a regulatory activity, which is then set as the submission id. Sequence numbers in this scheme are listed as a child, so to speak, of submission id.
Best practice with the new Module 1 implementation is for sponsors to include two points of contact (technical and regulatory). The information is being collected to improve communication by routing questions to the appropriate contact quicker.
If you’ll remember the FDA cites poor communication, not missing information or bad science, as the No. 1 reason for delay in submission approval.
Another form of dialogue was added at the behest of industry – submission description of up to 128 characters is now an optional text field.