Project Orbis Frequently Asked Questions

Historical

Q: Which countries were involved in the first Project Orbis collaborative review ?
A: The U.S. Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA) and Health Canada (HC) took part in this application review.

Q: For the first Project Orbis review, what was the role of each country in the review process?
A: The three regulatory agencies collaboratively reviewed this application, allowing for simultaneous decisions in all three countries. The aim of this collaborative review was to identify any regulatory divergence across the review teams.

Q: Did the three countries issue the same drug labels for the two products involved?
A: No. Each country has its own format for the drug label. The regulators exchanged drug labels to learn about any potential differences. Only minor differences were noted. In Canada, the approved indication was slightly different than the approved indication in the United States and Australia.

Q: This was an FDA accelerated approval. Does Canada and Australia have similar expedited approval programs?
A: Yes, Health Canada approved the 1st Project Orbis application under conditional approval with conditions and TGA used its provisional approval with conditions of registration.

Overview Questions

Q: Will other countries be involved in future Project Orbis reviews?
A: At this time, we are unable to increase the number of countries participating in Project Orbis. FDA is exploring other options to collaboratively work with regulators interested in this collaborative review program.

Q: Will other therapeutic areas be involved in future Project Orbis reviews?
A: Other therapeutic areas are not within the Oncology Center of Excellence’s purview.

Q: How does an application get nominated for Project Orbis?

A: The FDA review team can recommend an application for Project Orbis based on a combination of the following: breakthrough designation, impressive results, and unmet need. Sponsors can request Project Orbis for their applications.

Q: How does a sponsor make a Project Orbis request and what are the criteria?
A: Sponsors can inquire from the respective Office of Oncologic Diseases review divisions whether their proposed application submission would be suitable for Project Orbis. Criteria for consideration includes: high impact, clinically significant applications, should generally qualify for priority review because of improvement in safety/efficacy. The query should include topline efficacy and safety results that would support the application, as well as a global submission plan (GSP) that includes company points of contact and names/contacts of global affiliates.

Q. Will Project Orbis be used only for supplemental oncology approvals (new indications for previously approved therapies?
A: Project Orbis currently accepts New Drug Applications (NDA), Biologics License Applications (BLA), and supplemental applications for oncology indications.

Q: Any potential impact of Project Orbis participation on the FDA’s Real-Time Oncology Review (RTOR)?
A: An applicant can participate in Project Orbis, RTOR, or both programs. Participating in Project Orbis does not impact RTOR timelines. FDA follows its normal review timelines and processes. Project Orbis is collaborative, but each health authority retains their own timelines.

Q. Will FDA still provide rolling queries (i.e., information requests) to an applicant?
A: Yes

Q: Does a Project Orbis authorization apply for the life cycle of the application including supplements, or does it apply only up until the initial application approval?
A: The sponsor authorization applies only to the Project Orbis application for which it is submitted, whether the original application, or a supplement. For each subsequent application that will be reviewed under Project Orbis, a new sponsor authorization letter specifically citing the supplemental application number should be submitted.

Q: Can the FDA grant approval, even if the sponsor is still working on responding to queries from other countries?
A: Yes, the FDA follows its normal review timelines and processes.

Q: Is it mandatory for the sponsor to submit their application to all interested Project Orbis Partners?
A: FDA encourages submission of an application to all interested Project Orbis Partners/agencies; however, the final decision remains with the sponsor.

Q. Does the FDA share its data analysis with the other Health Authorities?
A: Yes

Q. Does Project Orbis have anything to do with drug pricing or drug importation?
A: No

Pre-submission

Q: What happens after an application gets nominated for Project Orbis?
A: The FDA review team notifies the OCE global team about the proposed Project Orbis application. The OCE global team will then reach out to the Project Orbis Partners (POPs) to consider whether they would like to collaborate on the review of a given application under Orbis.

Q: What happens after an application gets nominated for Project Orbis regarding sponsor acceptance?
A: The FDA team will notify the sponsor company regarding their acceptance into Project Orbis and indicate which Project Orbis Partners will be involved. The sponsor company should then send the Sponsor Authorization Letter (SAL) for those countries. Although SALs will not be required for countries not participating in Project Orbis, if the sponsor company plans to submit future applications to these other agencies, having an SAL on file would allow FDA to release minimally redacted reviews to non-participating Orbis countries.

Q: Does the Sponsor still need to hold pre-submission type meetings with each respective agency in order to inform additional local requirements for the application process prior to submission?
A: The sponsor would have to work with each country to determine whether pre-submission meetings are required, to confirm the regulatory requirements for each agency, and to negotiate pre-submission and submission timelines.

Q: Aside from providing the authorization letters, is there anything else that should be done to initiate Project Orbis?
A: Yes, the Global Submission Plan (GSP) should be submitted when topline efficacy and safety is provided to FDA. The GSP and topline data will be shared with POPs thereby allowing them to allocate resources should they participate in Orbis for the given application.

Q: Will Project Orbis hold an orientation meeting with the sponsor?
A: Typically, we do not have Project Orbis orientation meetings with the sponsors.

Submission/Review

Q: How is an application reviewed in Project Orbis?
A: POPs have regularly scheduled conference calls to collaborate and discuss evaluation of the application. Ultimately, each agency conducts their own review and retains independence of their final regulatory decision, labeling negotiations, and timelines.

Q: Will Project Orbis communications be finalized via email or letter?
A: We do not provide formal communications about Project Orbis we communicate with the applicant about Project Orbis as questions arise.

Q: Will requests for information from the FDA and Swissmedic be communicated through the FDA? How will the other regulatory agencies submit queries to the sponsor company?
A: Starting on January 2022 Swissmedic will communicate their information requests directly to the Swiss sponsor company. For pending Orbis applications submitted before 2022 Swissmedic will continue to issue IRs through FDA. All Orbis Health Authorities (HA) share information requests for comment from other HAs prior to sending or shortly after sending if urgent. Queries received from TGA, HC, UK MHRA, HSA and ANVISA will be sent directly to the regional sponsor.

Q: How are information request handled in Project Orbis? Should the sponsor company send information request (IR) responses to each Health Authority (HA) participating in Project Orbis?
A: Each agency can issue information requests (IRs) to the sponsor company and/or local affiliate, but in order to minimize duplication, the POPs share the IRs for comment and review prior to sending to the sponsor company/local affiliate. The sponsor teams should send the IR response(s) to all HAs that have received the application. Responses to POPs IRs, should be submitted to the FDA in Module 1.11 as a single file. For those HAs who have yet to receive the application, please confirm if and how they would like to receive the IR responses that were submitted to the POPs prior to the dossier submission at their agency.

Q: Does the sponsor have to submit responses to the FDA from POPs information requests after the FDA has already taken action regarding application?
A: The sponsor should check with their respective FDA team to see how/if they want to see responses to POP IRs after the FDA has taken action on an application.

Q: Does SwissMedic follow a clock-stop timeline for Project Orbis applications?
A: No, Swissmedic does not follow a clock-stop, neither for Orbis nor for other application types. The clock is still running while SMC waits for IR responses.

Q: Will there be a teleconference with all Project Orbis Partners and their respective Sponsors to discuss logistics in terms of how questions and responses are shared?
A: No, the FDA does not hold a teleconference with all POPs and respective sponsors. After POPs receive the submission, Information Requests are shared amongst POPs for feedback and then sent to the respective/regional sponsors.

Q: Once the application has been approved, is the FDA still in regular communication with the Project Orbis Partners (POP) regarding their respective applications?
A: Yes. From an overall Project Orbis perspective, FDA tracks the outcome of all Project Orbis applications. From an application-specific perspective, all POPs including FDA can communicate with each other as needed regarding the application.

Additional Information

Contact Information

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