Exploring alternative submission pathways

Access is steered and directed by the heads of participating regulatory authorities, who meet at least twice a year to review progress, define the consortium’s strategic direction and advance goals and objectives.⁵ 

A coordinator from each agency ensures effective communication between all members and coordinates the work carried out by experts in the various working groups, including generic medicines, biosimilars, new active substances and advanced therapy medicinal products (ATMPs).4 These groups meet regularly to exchange information on regulatory issues regarding marketing authorizations, inspections of manufacturing sites, clinical studies, technical guidelines or regulatory standards and efforts to harmonize assessment approaches. 

Each group has similar requirements. As an example, the New Active Substance Work Sharing Initiative (NASWSI) requires interested companies to fill in an "expression of interest" (EOI) form three months in advance. Identical dossiers should be sent to all participating authorities within a timeframe of two weeks. While Modules 2 to 5 do not have to be identical, it is preferable that the same dossiers are submitted to all participating authorities, with any differences outlined in the EOI form.⁶ 

Each authority will review the module or modules they have been allocated, and evaluations are shared on a secure platform and peer reviewed, with results being discussed before a consolidated response is sent to the applicant. In practice, Module 3 is typically handled by Health Canada when the agency is involved in the procedure. Product labeling is not part of this joint review and is handled on a national basis. 

Any clarification questions are consolidated and sent to the applicant simultaneously. Timelines for sharing questions depend on the milestones for review and are agreed by the participating regulators. Some activities will be country-dependent, such as questions for a specific jurisdiction or timelines when using a country’s priority pathway in the evaluation. The final decision of each authority is independent, and certain national procedures will still apply for posting an external summary of the application, for example the U.K. Public Assessment Report (PAR),⁷ AusPAR,⁸ Canadian Summary Basis of Decision⁹ and SwissPAR.¹⁰ 

While the processes and benefits are clear, all agencies must regard the proposed product in the same way (for example, as a generic, new active substance or ATMP), and all dosage forms will need to be eligible for the work-sharing initiative to proceed. Any major differences, such as submitting multiple studies using different comparator products, would likely mean the application is not suited for Access.

Acceptance is contingent upon meeting key criteria, including that the product is clinically significant or has compelling data demonstrating improved safety or efficacy. Sponsors are expected to work with the local authority to determine whether pre-submission meetings are required and must commit to supporting submission of applications in similar timeframes in all participating markets. Applicants are also asked to ensure responses to requests for information from specific agencies are provided to all participating agencies to minimize duplication and improve efficiencies. 

When a project is identified, the FDA sends Project Orbis partners a proposal to confirm their interest and availability to participate in the review process. The FDA remains the primary coordinator of the process. A minimum of two agencies must participate in the project. 

There are three types of collaboration under Project Orbis.¹¹ Type A is when the application is submitted less than 30 days from FDA submission. Type B is when the application is submitted more than 30 days after the FDA submission or regulatory action is more than three months from the FDA action. Type C is any time after the FDA submission has been made and FDA action has concluded. There is a multi-country review meeting for Types A and B, but not C, since in this last instance the FDA process has been completed. 

To maximize collaboration opportunities with the FDA, Type A and B Orbis applications will not be batched, and the submission phase will generally align with any priority review process each agency may have. Type C Orbis applications will follow the standard pathway. 

Project Orbis partners prepare their own Information Requests (IRs) for modules covered by the Orbis procedure based on their evaluation of the dossier.¹¹ It is common for Project Orbis partners to issue "rolling questions" throughout the assessment phase. Given the nature of the Project Orbis evaluation process, it is not possible to predict in advance when IRs will be issued during the evaluation period. 

Due to the collaborative nature of Project Orbis, any regulatory pathways that may impact the timeline, for example the priority review pathway in Australia,¹² should be aligned. While participating authorities collaborate during the evaluation process, each authority remains fully independent with regard to regulatory decisions, which may result in differences in the approval or rejection of marketing authorization, as well as differences in the wording of the indications and post-market surveillance requirements. 

While participation in Project Orbis can be demanding due to the parallel independent review by potentially eight different regulatory authorities, there is real collaboration between the agencies, which can save time and resources thanks to the use of common dossiers, shared evaluation questions and responses, and faster evaluation timelines. As of October 2026, with Japan’s PMDA added, that number is nine.³

Disclaimer:
Informațiile din acest articol au scopul de a informa cititorii despre un subiect legat de capacitățile Cencora și nu reprezintă sfaturi juridice sau de cumpărare. Cencora, Inc. încurajează cititorii să revizuiască referințele citate în acest articol și să-și folosească propriile cunoștințe și experiență atunci când iau decizii.