Project Orbis

Project Orbis is an international partnership designed to give cancer patients faster access to promising cancer treatments. Learn more about the project, eligible products and the steps to apply.

On this page

• Project Orbis
• Products eligible for Project Orbis
• Submission for Project Orbis
• Selection of submission into Project Orbis
• Types of Project Orbis collaborations
• Health Canada assessment timeline for Project Orbis submissions
• Role of each regulatory authority in the review process
• Publication of regulatory action from Project Orbis

Project Orbis

Project Orbis is an initiative of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence. It aims to give patients faster access to promising cancer treatments across the globe. Project Orbis partners work together on the review of submissions for cancer drugs. Each Project Orbis partner is an international regulatory agency with a confidentiality agreement in place.
In addition to the US FDA, Project Orbis partners include:

• the Health Sciences Authority (HSA) of Singapore
• the Therapeutic Goods Administration (TGA) of Australia
• the National Health Surveillance Agency (ANVISA) of Brazil
• the Swiss Agency for Therapeutic Products (Swissmedic) of Switzerland
• the Health Products and Food Branch (HPFB) of Health Canada, Canada
• the Medicines and Healthcare products Regulatory Agency (MHRA), of the United Kingdom (U.K.)
• the Ministry of Health of Israel

Health Canada has been a partner in Project Orbis since its inception in May 2019. Health Canada worked with the FDA and TGA on the first Project Orbis submission. This led to Health Canada's timely approval of a treatment for women with advanced endometrial cancer in September 2019. Since then, Health Canada has participated in many Project Orbis submissions. The collaborative effort of this project helps Health Canada bring new cancer treatments to Canadians more quickly.

Products eligible for Project Orbis

Products eligible for Project Orbis include oncology products that are either:

• new active substances
• new indications for previously approved drugs

Project Orbis submissions are expected to meet:

• the criteria for "FDA Priority Review"
• one of Health Canada's expedited review pathways, either the:
• Priority Review or
• Advance Consideration for a Notice of Compliance with Conditions (NOC/c)

Qualifying criteria for Health Canada priority review include:

• drugs that intend to treat a serious condition for which no drug is currently marketed in Canada
• drugs that would provide improved overall benefit/risk profile for a condition adequately managed by marketed drugs

Eligibility for advanced consideration for a NOC/c include promising drugs intended for the treatment, prevention or diagnosis of serious diseases or conditions for which:

• there is no alternative therapy available on the Canadian market
• the new drug offers a significant improvement in benefit/risk profile over existing products

Submission for Project Orbis

Sponsors need to address the FDA with their initial inquiries about submission to Project Orbis. Project Orbis Partners refer initial queries they receive to the FDA.
As with any submission to Health Canada, a marketing submission identified as a Project Orbis collaboration should:

• conform to Health Canada submission requirements

Selection of submissions into Project Orbis

The FDA coordinates the selection of applications for Project Orbis.
Either the FDA or the U.S. sponsor can propose an application for Project Orbis. Projects selected for Project Orbis have high-impact and clinically significant applications.
The FDA then sends a proposal to the project partners to confirm their:

• interest
• availability to participate

Sponsors can select the number of partners included in a Project Orbis submission. Sponsors must select at least 2 partners, including the FDA.
Once the Project Orbis partners are identified, FDA confirms the global submission plan through the U.S. sponsor. The Project Orbis working group for each submission will consist of FDA and the participating Project Orbis partners.

Types of Project Orbis collaborations

There are currently 3 types of Project Orbis collaborations^{Footnote 1}. They are classified based on the submission and review timelines between the FDA and the participating Orbis partners. In addition, partners have the flexibility to determine which type of collaboration is possible for them.

Type A (Regular Orbis)

Sponsors need to file submissions with the Project Orbis partner within 30 days of submitting it to the FDA for it to be considered a Type A Orbis.
Type A Orbis allows for maximal collaboration during the review phase, including:

• sharing of reviews
• exchanging requests for clarification
• participating in multi-country discussions

Type B (Modified Orbis)

Type B Orbis are those in which sponsors file submissions to Project Orbis partners more than 30 days after filing with the FDA.
Type B Orbis have less collaboration through the whole FDA review. Type B Orbis allows Project Orbis partners to:

• receive FDA review reports
• exchange or receive requests for clarification
• observe and participate in some multi-country meetings

There is the potential for concurrent or overlapping review.

Type C (Written Report Only Orbis)

Type C Orbis submissions include those where the FDA has already issued a positive decision. In these submissions, the FDA shares their completed review documents with the Project Orbis partners. The Project Orbis partners will not have concurrent review or concurrent action with the FDA.

Health Canada assessment timeline for Project Orbis submissions

Our regulatory review service standards do not change with Project Orbis submissions. However, under Project Orbis, we may review some submissions and make decisions faster than our service standard.
Many factors affect assessment timelines, including:

• existing workload and priorities
• timing of the submission to Health Canada relative to other jurisdictions

Sponsors are encouraged to follow the existing guidance if a submission may qualify for 1 of Health Canada's expedited review pathways, either the:

• Priority Review or
• Advance Consideration for a Notice of Compliance with Conditions (NOC/c)

Role of each regulatory authority in the review process

Project Orbis promotes collaboration amongst its partners. However, each participating regulatory authority remains fully independent with regard to the regulatory decision-making for each application under their jurisdiction.
Each Project Orbis partner will consider their country-specific:

• laws
• policies
• ordinances
• regulations
• practice of medicine

This may result in differences in:

• the approval or rejection of marketing authorization
• the content of the labeling
• the wording of the indications
• country-specific post-market surveillance requirements

Publication of regulatory action from Project Orbis

Submissions reviewed under Project Orbis remain subject to Health Canada's transparency initiatives. As with all other qualifying submissions, we will:

• add it to the submission under review (SUR) list
• publish a Summary Basis of Decision or Regulatory Decision Summary when applicable