Project Orbis

About Project Orbis

Project Orbis is an initiative of the US Food and Drug Administration (FDA) Oncology Center of Excellence. It provides a framework for the collaborative review of oncology products among international regulatory partners. Project Orbis is coordinated by FDA, and it involves the regulatory authorities of the following countries:

• Australia - Therapeutic Goods Administration (TGA)
• Brazil - Agência Nacional de Vigilância Sanitária (ANVISA)
• Canada - Health Canada
• Israel - Ministry of Health
• Singapore - Health Sciences Authority (HSA)
• Switzerland - Swissmedic
• United Kingdom - Medicines and Healthcare products Regulatory Agency (MHRA)

Application selection

FDA coordinates the selection of candidates for Project Orbis in collaboration with the US applicant. Once a potential candidate is identified, FDA will send a proposal to the Project Orbis partners (POPs) to confirm their interest and availability to participate in the collaborative review process. HSA will consider the type of collaboration taking into account our local context including medical needs and priorities.

Types of Project Orbis collaboration

There are different types of Project Orbis collaborations based on the submission timeline between the FDA and POPs.

Type A

Application should be submitted concurrently or near-concurrently (within 30 days) to FDA and POPs. Type A Orbis provides the possibility for concurrent review and action with FDA.

Type B 

Application submitted more than 1 month of FDA submission. Type B Orbis allows the possibility of concurrent review with FDA but no concurrent action.

Type C

Type C Orbis facilitates regulatory reliance whereby FDA shares its completed review documents with POPs. There is no concurrent review or action with FDA.

 

Project Orbis Types

Orbis Type	Submission Timeline	Submission overlaps with FDA	Sharing of FDA reviews	Multi-country review meetings (POP TCONs)	POP Attendance at FDA review meetings	Concurrent review with FDA	Near concurrent action with FDA
Type A	Application submission to POPs ≤ 1 month of FDA submission	Expected	Yes	Yes	Yes	Expected	Possible1
Type B	Application submission to POPs > 1 month of FDA submission	Expected	Yes	Yes	Yes	Possible	No1
Type C	Any time after FDA submission2	Permitted2	Yes	No	Unlikely	Unlikely	No1

1 Regulatory action in other jurisdictions is unlikely to occur immediately after FDA action and will follow respective health authority timelines.
2 Dependent on Project Orbis Partner (POP) guidelines. Contact specific POP(s) regarding optimal timing for submission of Type C dossier.
Reference: FDA website

Application submission, assessment process and regulatory decision

The application submission, documentary requirements, assessment process, fees and processing time follow the standard procedures as per HSA registration guides for therapeutic products.

The local applicant will be required to provide the relevant Information Requests (IRs) and responses from the FDA’s and POPs’ review of Project Orbis applications for all Project Orbis types. For Type A Orbis, HSA IRs will be shared with the participating agencies for review and comment before they are sent to the local applicant.

Project Orbis promotes collaboration amongst its partners. However, each regulatory authority remains fully independent on their final regulatory decision. Applications reviewed under Project Orbis will be reflected in the HSA website listing of new drug approvals and new indication approvals.