P323: Accelerating Global Regulatory Approvals: Lessons from ORBIS and Non-ORBIS Submission Strategies
Poster Presenter
Gargi Roy
Regulatory Affairs Associate
Servier Canada Canada
Objectives
This study evaluates the impact of parallel submissions through ORBIS and the EMA centralized procedure on approval timelines, regulatory alignment, and operational requirements for an oncology product across multiple regions.
Method
In this case study, parallel submissions to the US, six ORBIS countries and the EMA were analyzed. Pre-submission activities, priority review, timelines, Health Authority questions, labeling, and resource needs were compared.
Results
Parallel planning enabled near-concurrent submissions across regions, with earlier filing achieved in several ORBIS countries. Specifically, in Switzerland, Canada, and Australia, the submissions occurred within 4 weeks of the initial US submission. Priority review was requested or strongly recommended in Canada and Australia to enable ORBIS Type A and B participation. Review durations exhibited significant disparity when stratified by Project Orbis classification; while Canada, Switzerland, and Israel all conducted Type A reviews, timelines ranged from 7 to 10 months. Notably, Type C submissions saw the greatest variance, with an expedited 5-month turnaround in the UK contrasted by a protracted 18-month process in Brazil. Of note, Australia was submitted via Type B procedure and assessment lasted 10 months.
Project ORBIS Partners questions and responses management posed major operational challenges. With a mean volume of 111 questions per country, significant variability emerged across domains, ranging from one Clinical question in Israel to 54 in Canada. Through the registration procedure, time to submit responses to questions from Project ORBIS Partners ranged from 1 to 80 days with a median time to submit of seven days.
Regulatory decisions were overall aligned across ORBIS countries, although region-specific differences were required to meet national requirements. In addition, while approval was obtained in all ORBIS countries, differences in labeling, including aspects of the indication, were observed.
Main divergence was observed between the ORBIS countries and the EU with respect to overall assessment timelines (20 months in the EU compared to an average of 9.6 months across ORBIS partners). This had an impact on the initial submission strategy for the United Kingdom, which was ultimately submitted through ORBIS Type C procedure (5 months review duration) in agreement with the UK MHRA.
Conclusion
Submission sequencing depends on multiple factors including patient needs, legal aspects, supply, market access, etc. There are several regulatory opportunities particularly in oncology such as Project ORBIS allowing to accelerate patient access to drugs.
This case study demonstrates that ORBIS filing enables earlier submissions, especially in Australia, Canada and Switzerland and, in some jurisdictions, shorter approval timelines compared with standard regional filings, thereby supporting faster patient access. However, timeline gains vary among participating countries due to differences in national implementation and review capacity. These variations reflect specific national requirements applied by individual ORBIS authorities.
Effective strategy requires careful anticipation of the volume and timing of Health Authority questions, rapid cross-functional response capability, and strong global coordination to manage overlapping review cycles. While regulatory outcomes are largely aligned across ORBIS countries, national labeling adaptations remain necessary.
In this case, a major scientific distinction persists between Project ORBIS regulators and the EMA, particularly regarding nonclinical data expectations, which contributed to the prolonged EU review timeline.
