Collaborative Regulatory Pathways: Navigating Global Approvals with Access Consortium and Project Orbis

The global regulatory landscape is becoming more standardized, thanks to initiatives like ICH guidelines and technical requirements. However, significant variations still exist across different markets. In response, health authorities are increasingly adopting collaborative models to bring greater efficiencies to their regulatory processes. These partnerships aim to streamline reviews, reducing duplication and providing faster access to new medicines. Two key initiatives driving this trend are the Access Consortium and Project Orbis, both of which foster international cooperation and harmonization. 

Understanding these regulatory pathways can help biopharmaceutical companies navigate the complexities of submitting marketing authorization applications (MAAs) and determine the most effective approach for their global strategy. 

The Access Consortium: Facilitating Near Simultaneous Approvals 

The Access Consortium is a collaborative group of regulatory authorities from Australia’s Therapeutic Goods Administration (TGA), Swissmedic, Health Canada, the Health Sciences Authority (HSA) of Singapore, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This consortium enables biopharmaceutical companies to obtain near simultaneous marketing authorization approval in participating countries, ensuring timeline predictability and a coordinated review process. 

Key Benefits of Access Consortium for Industry: 

• Single Submission: Companies can submit one eCTD dossier for all countries involved, simplifying the process and reducing administrative burdens. 

• Consolidated Questions: Participating authorities provide a unified list of questions, streamlining the review process and minimizing redundancy. 

• Simultaneous Evaluation: A coordinated review process, often resulting in faster approval times. 

• Near Simultaneous Approvals: Marketing authorizations in multiple countries can be granted almost simultaneously, depending on each nation’s final decision. 

The consortium’s collaborative structure involves regulatory authorities meeting biannually to review progress and set strategic goals. A dedicated coordinator from each agency ensures smooth communication and efficient collaboration among the members, including experts in various areas such as biosimilars, new active substances, and advanced therapy medicinal products (ATMPs). 

Considerations for Access Consortium Participation: To participate in the Access Consortium, applicants must submit a dossier to at least two of the consortium members. While modules 2-5 of the submission may differ slightly between authorities, it is essential to maintain consistency to ensure the success of the initiative. 

Additionally, each participating authority reviews the dossier independently and shares evaluations on a secure platform. Questions from all authorities are consolidated and sent to the applicant at the same time, further reducing duplication and streamlining communication. 

Project Orbis: Accelerating Oncology Approvals Through Collaboration 

Project Orbis is a global initiative led by the US Food and Drug Administration’s (FDA) Oncology Center of Excellence. It enables concurrent submission and review of oncology products across multiple international regulators, including the Access Consortium members, Brazil’s National Health Surveillance Agency (ANVISA), and Israel’s Ministry of Health Pharmaceutical Administration. 

The goal of Project Orbis is to expedite the approval of cancer treatments by increasing transparency and collaboration between global regulators. This initiative allows applicants to submit a single application to multiple authorities and undergo simultaneous reviews, reducing time-to-market for life-saving treatments. 

Types of Collaboration Under Project Orbis: 

• Type A: The application is submitted to other regulators within 30 days of the FDA submission. 

• Type B: The application is submitted more than 30 days after the FDA submission, or regulatory action occurs more than three months after the FDA’s action. 

• Type C: The FDA submission has been made, and the FDA process is complete. 

While each authority maintains its independence in decision-making, Project Orbis facilitates the use of shared dossiers, rolling questions, and coordinated evaluation processes. This collaboration can result in faster approval timelines and greater regulatory alignment, although regulatory decisions, such as post-market surveillance requirements, may still differ. 

Key Benefits of Project Orbis for Oncology Drug Development: 

• Parallel Reviews: Multiple regulatory authorities review the same dossier, speeding up the approval process. 

• Reduced Duplication: With shared evaluation questions and responses, companies can avoid duplicating efforts across different markets. 

• Increased Access to Treatments: Faster regulatory approvals allow life-saving oncology treatments to reach patients more quickly. 

The Growing Trend Toward Global Collaboration in Regulatory Review 

Initiatives like the Access Consortium and Project Orbis represent the future of global regulatory processes. These collaborative efforts not only reduce the burden on individual regulators but also help biopharmaceutical companies streamline their submission strategies, enhance regulatory efficiency, and bring essential medicines to market faster. 

For companies navigating the complexities of international submissions, understanding and leveraging these collaborative pathways can be a key factor in expediting the approval process and achieving success across multiple markets. 

Partner with BioBoston Consulting for Expert Guidance on Global Regulatory Strategies. 

At BioBoston Consulting, we specialize in helping pharmaceutical and biotechnology companies navigate the complexities of global regulatory requirements. Whether you are exploring the benefits of the Access Consortium or considering participation in Project Orbis, our experts can guide you through the nuances of these collaborative pathways, ensuring your marketing authorization applications are submitted efficiently and effectively. 

Ready to accelerate your regulatory submissions? Contact BioBoston Consulting for expert support in navigating global regulatory pathways and bringing your medicines to market faster.