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Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners
Lauren T Hotaki1, Anu Shrestha2, Monica P Bennett3
1U.S. Food and Drug Administration, Oncology Center for Excellence, Silver Spring, MD, USA. lauren.hotaki@fda.hhs.gov.
Abstract:
Project Orbis was initiated in May 2019 by the Oncology Center of Excellence to facilitate faster patient access to innovative cancer therapies by providing a framework for concurrent submissions and review of oncology products among international partners. Since its inception, Australia's Therapeutic Goods Administration (TGA), Canada's Health Canada (HC), Singapore's Health Sciences Authority (HSA), Switzerland's Swissmedic (SMC), Brazil's National Health Surveillance Agency (ANVISA), United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA), and most recently Israel's Ministry of Health (IMoH) Medical Technologies, Health Information, Innovation and Research (MTIIR) Directorate, have joined Project Orbis. While each country has its own expedited review pathways to bring promising therapies to patients, there are some similarities and differences in pathways and timelines. FDA's fast-track designation and MHRA's marketing authorization under exceptional circumstances (MAEC) allow non-clinical and limited clinical evidence to support approval under these programs. HC's Extraordinary Use New Drug (EUND) pathway allows granting exceptional use authorization with limited clinical evidence. ANVISA, HSA, MTIIR, and TGA do not have standard pathways that allow non-clinical evidence and limited clinical evidence. While there is no definite regulatory pathway for HSA, the current framework for approval does allow flexibility in the type of data (non-clinical or clinical) required to demonstrate the benefit-risk profile of a product. HSA may register a product if the agency is satisfied that the overall benefit outweighs the risk. All Project Orbis Partner (POP) countries have similar programs to the FDA accelerated approval program except ANVISA. Although HSA and MTIIR do not have defined pathways for accelerated approval programs, there are opportunities to request accelerated approval per these agencies. All POP countries have pathways like the FDA priority review except MHRA. Priority review timelines for new drugs range from 120 to 264 calendar days (cd). Standard review timelines for new drugs range from 180 to 365 cd.
Insights
Project Orbis enables faster patient access to new cancer drugs through international collaboration. It harmonizes regulatory reviews across multiple countries, streamlining the approval process for innovative oncology therapies.
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.
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