Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners

Area of Science:

• Oncology
• Regulatory Science
• Pharmaceutical Policy

Background:

• Project Orbis was launched in May 2019 by the Oncology Center of Excellence.
• It aims to expedite patient access to innovative cancer therapies.
• It provides a framework for concurrent submissions and reviews among international regulatory partners.

Purpose of the Study:

• To outline the framework of Project Orbis.
• To compare the expedited review pathways of participating countries.
• To identify similarities and differences in regulatory timelines and data requirements.

Main Methods:

• Review of regulatory pathways of Project Orbis Partner (POP) countries.
• Comparison of expedited review programs (e.g., fast-track, priority review, exceptional use).
• Analysis of data requirements (non-clinical and clinical evidence) for drug approval.

Main Results:

• Project Orbis includes regulatory agencies from Australia (TGA), Canada (HC), Singapore (HSA), Switzerland (Swissmedic), Brazil (ANVISA), UK (MHRA), and Israel (IMoH MTIIR).
• Participating countries have varying expedited pathways; some allow non-clinical and limited clinical data (e.g., FDA, MHRA, HC), while others require more comprehensive evidence (e.g., ANVISA, HSA, MTIIR, TGA).
• Most POP countries have accelerated approval programs similar to the FDA's, except ANVISA, and priority review pathways, except MHRA, with varying review timelines.

Conclusions:

• Project Orbis facilitates international collaboration for faster drug approvals.
• Differences in national regulatory pathways necessitate careful planning for concurrent submissions.
• The initiative streamlines access to novel oncology treatments for patients globally.