The Science of Simultaneous Submissions: Managing Multiple Regulatory Pathways

Bringing innovative therapies to patients worldwide no longer necessitates sequential engagement with regulatory agencies. The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) are increasingly aligned in data expectations. For companies developing new therapies, this growing collaboration among regulators creates the possibility of near-simultaneous submissions. However, this requires clear planning both prior to and, importantly, following the concurrent submissions

At Veristat, we have supported more than 190 marketing applications globally, including over 90 in the past five years. Many were planned and delivered across multiple agencies within the same review window. From that experience, we have developed a clear, step-by-step approach for sponsors who are considering simultaneous submissions and want to understand what it takes to plan, coordinate, and deliver them successfully.

Step 1 – Map the Global Path Early

The foundation for simultaneity is laid long before data lock. Sponsors should set global regulatory goals early, ideally before pivotal studies begin, and decide which agencies to approach. Early engagement through scientific-advice meetings with regulatory authorities helps identify potential differences in requirements across the regions allowing for appropriate adjustments to submission requirements. If appropriate, request parallel scientific advice with FDA and EMA.

Historically, FDA and EMA dossiers were prepared separately, each reflecting distinct national traditions. That changed with the introduction of the International Council for Harmonisation (ICH) Common Technical Document (CTD), which allows companies to prepare one core dossier that is accepted across regions. Modules 2 through 5 of the CTD contain shared scientific content, while Module 1 captures region-specific details, including labeling.

Action Tip: Create a global submission roadmap that links milestones across regions. Work backward from your earliest target submission date and define dependencies among data cuts, analyses, and dossier preparation. Treat every region as part of a single plan, not a separate effort. Map out the requirements for prescribing information across the regions early to ensure that the dossier supports all key information needed to support the proposed indication and the therapy’s efficacy and safety.

Step 2 – Build a Common Dossier Core

Once the plan is set, build a single “core” set of submission documents that, as needed, can be adapted for each region. Using a consistent structure saves time and minimizes the risk of conflicting information. Establish a master library for key documents and data summaries so that updates are applied once and shared everywhere.

Action Tip: Assign ownership for each section of the dossier and schedule shared reviews. Agree on key messages, terminology, document templates, reviewers, method for review, and version control before authoring begins to avoid inconsistencies and to streamline the process.

Step 3 – Coordinate Data and Documentation

Synchronizing data and documents is the most complex part of parallel submissions. Analytical outputs, statistical summaries, and medical writing must all move forward together. Aligning data and writing standards early with statistical analysis plans; mock table, listing and figure shells; and document shells ensures that results, once available, can be seamlessly incorporated into the relevant documents.

Regulators approach reviews differently: the FDA often begins by drilling into detailed datasets, while the EMA tends to start with the overall clinical story before testing the underlying data. A strong submission supports both views, presenting a clear narrative that is fully backed by consistent evidence.

Action Tip: Hold regular cross-functional meetings among clinical operations, data management, statistics, programming, medical, safety, medical writing, and regulatory teams. Timelines for submissions are tight following database lock. Include calendar blocked reviews for each draft of each document so that the team is clear on expectations.

Step 4 – Govern the Process as One Program

Coordinating multiple submissions requires unified oversight. Designate a global submission lead with authority to manage priorities across regions. Create one master timeline and risk log that all contributors follow. Shared visibility reduces duplication and prevents delays when one region’s milestone shifts.

Action Tip: Use a single project dashboard that tracks progress, dependencies, and issues in real time. Keeping all contributors informed supports consistent execution across agencies.

Step 5 – Confirm Readiness Before Submission

When planning to file with several agencies, readiness must be verified at both the scientific and technical levels. Confirm that every dataset, summary, and module aligns across regions (as applicable) and meets each authority’s gateway and formatting requirements.

Checklist:

• Module 1 materials meet each region’s administrative and labeling conventions.

• Modules 2 through 5 are complete.

• Datasets comply with CDISC standards.

• Final quality control checks for external links are complete.

Action Tip: Schedule a single global “go/no-go” review to confirm that all packages are complete and aligned before any are submitted.

Step 6 – Account for Different Review Timelines

The work does not stop at submission. Even with greater harmonization, each agency maintains its own review style and pace of review. Anticipating these differences helps sponsors prepare for regulatory requests and questions – which come with strict timelines for response. Having the team prepared for this is critical to keep the approval timelines on target.

Action Tip: During the preparation of the dossier, keep a running list of potential questions based on study results. Designate a cross-functional rapid response team that will review incoming regulatory questions, designate response teams, and respond in the required time.

Step 7 – Capture and Respond: Learning From Regulatory Queries

Sponsors should expect—and plan for— early clarification requests, information queries, or targeted follow-ups from regulators after submission. Preparing in advance for these inquiries helps teams respond quickly and consistently across regions. Before submission, teams should anticipate the likely areas of inquiry, assign ownership for specific types of questions, and maintain an organized library of supporting analyses and justification materials to reference quickly when queries arise. Rapid, well-coordinated replies not only keep reviews on schedule but also demonstrate credibility with the agencies. Recording what worked and what caused rework helps improve future submissions and approval success.

Action Tip: Form a dedicated regulatory response team, if feasible, before submission, that is equipped to triage queries, draft coordinated replies, and track correspondence across agencies. After each submission cycle, hold a debrief with all contributors to capture lessons learned, update internal templates, and refine response strategies for future filings.

The Emerging Global Standard

Regulators are steadily converging toward shared expectations in both data standards and scientific evaluation. Initiatives such as the FDA–EMA Parallel Scientific Advice program, Project Orbis, and joint reviews with Health Canada and PMDA signal a long-term move toward coordinated global assessment.

For sponsors, this convergence means global planning is no longer optional. Designing for simultaneity strengthens scientific consistency, reduces duplication, and brings therapies to patients faster. Companies that prepare for multi-agency submissions early position themselves for faster decisions and more coherent global development programs.

Veristat's Persepctive

As global regulators continue to align review processes, sponsors have an opportunity to rethink how and when they engage multiple agencies. Early coordination can shorten overall timelines, strengthen data consistency, and improve regulatory confidence. To explore whether a simultaneous submission strategy makes sense for your next program, contact Veristat’s experts to discuss planning considerations, feasibility, and best practices.

Visit veristat.com to learn more.