By Allison Steffen
The DIA Regulatory Submissions, Information, and Document Management (RSIDM) Conference was held in February again this year. As always, it provided a space for the regulatory community to exchange insights, discuss emerging trends, and explore different dimensions of regulatory submissions and the information and documents that comprise them.
The Power of Peer Discussions
While FDA representatives were absent this year due to new communication policies under the current administration, the presence of agencies like Health Canada, SwissMedic, and other European regulatory bodies brought valuable perspectives to the discussions. The industry’s collaborative spirit was on full display as attendees shared experiences, best practices, and strategies for navigating the ever-changing regulatory environment.
Change Management and Emerging Technology
One of the dominant themes throughout the conference was change management and emerging technology. As regulatory submissions become increasingly complex, organizations must adopt new technologies and develop strategies to integrate them into their workflows. The shift is not just technical, it requires a cultural transformation within regulatory teams to embrace innovation while maintaining compliance and efficiency.
eCTD 4.0 – The Present Progress
A particularly hot topic was eCTD 4.0, with the FDA currently conducting a limited pilot that only accepts new applications. While the U.S. is in its early phases of adoption, Japan has been using eCTD 4.0 since 2022.
Europe is also making strides, running its own pilot and requesting sample applications from different tools. The first phase of the pilot started in the last quarter of 2024 and the second phase will begin in the first half of 2025, where marketing authorization holders/applicants will submit simple test applications for feedback. A subsequent phase planned for the second half of 2025 will test more complex scenarios, such as grouped submissions and forward compatibility of eCTD 3.2 submissions.
The slow start of eCTD 4.0 has led to some hesitation, but the consensus at the conference was clear—it is here, can offer us advantages, and the industry is making progress toward implementation and use.
Collaboration Driving Industry Advances
Beyond submission formats, the regulatory community is working together to push progress on multiple fronts. Whether it’s through collaborative discussions, knowledge-sharing, or aligning expectations across agencies, the collective effort to streamline regulatory processes is gaining momentum.
ESG NextGen Portal – A Technological Leap
The conversation around ESG NextGen Portal underscored this effort. Having been in testing since last summer, the portal is set for implementation in 2025 and promises significant improvements, including enterprise identity and access management. From better cloud storage capabilities to increased support for larger-scale submissions, this next-generation tool represents a much-needed upgrade that aligns with the growing demands of regulatory submissions.
AI in Regulatory Submissions – Aiding, Not Replacing
Artificial intelligence also took center stage in many discussions, and opinions varied widely. While some still view AI as a potential disruptor, today's most successful applications appear to be in small, targeted projects rather than sweeping automation. Instead of attempting to draft an entire clinical study report (CSR), organizations are finding value in using AI for more focused tasks, such as generating tables or summaries, with human oversight ensuring accuracy and context. The current state of AI in regulatory submissions is not about replacing humans but rather augmenting their capabilities, enhancing efficiency while maintaining the expertise needed for compliance.
IDMP – Global Harmonization Gaining Momentum
Global collaboration is also apparent in the Identification of Medicinal Products (IDMP) harmonization efforts. With input from EMA, Health Canada, and Brazil’s regulatory agency, it is clear that momentum is building for a standardized approach to medicinal product data. As regulatory agencies align on language and data structures, industry stakeholders will reap benefits like integrated global signal management and more accurate comparisons of drug information across regional and country databases.
Project PRISM – The Future of Cloud Collaboration
Finally, Project PRISM stood out as an exciting forward-looking initiative. Its emphasis on cloud collaboration signals a shift in how regulatory teams manage documents, submissions, and agency interactions. Private and shared spaces will enable more efficient interactions, and users will be able to use shared tools to support the interactions while ensuring the security of their files and communications. As the industry moves toward more digital, interconnected solutions, the promise of enhanced collaboration and streamlined processes is within reach.
The Road Ahead
Despite regulatory complexities and evolving requirements, the tone of the conference remained optimistic. The industry is not just reacting to change; it is actively shaping the future. Regulatory professionals are driving meaningful progress through collective efforts, shared insights, and strategic adoption of technology. The road ahead will require continued adaptation, but the momentum is unmistakable. The regulatory landscape is evolving, and those who embrace innovation and collaboration will be well-positioned for success.
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