UK MHRA Project Orbis: Accelerating Global Access to Innovative Cancer Medicines Through International Regulatory Collaboration

Sharan Murugan
2 hours ago
3 min read

The global regulatory landscape for oncology medicines is increasingly moving toward collaborative review models that enable faster patient access to innovative treatments. One of the most significant initiatives in this area is Project Orbis, a multinational programme that allows concurrent submission and review of promising cancer medicines across several international regulatory authorities.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) guidance on Project Orbis, last updated on 22 May 2026, outlines how the programme operates, the types of products eligible for inclusion, the submission pathways available to sponsors, and the role of international regulatory collaboration in accelerating access to oncology therapies.

Project Orbis is an international regulatory collaboration programme designed to facilitate the concurrent review of oncology products among multiple regulatory authorities. The initiative aims to provide patients with faster access to innovative cancer treatments while maintaining robust standards of quality, safety, and efficacy.

The programme was established by the US Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) in 2019 and has since expanded to include several global regulatory partners.

The MHRA joined Project Orbis in January 2021 and issued its first approval under the programme in May 2021 for osimertinib (Tagrisso) as a treatment for certain patients with non-small cell lung cancer

Scope of Project Orbis

Project Orbis focuses specifically on oncology products and applies to:

New marketing authorisation applications for cancer medicines
New oncology indications for already authorised products
Innovative therapies that may provide significant clinical benefit over existing treatments

International Regulatory Partners

Project Orbis is coordinated by the FDA and involves collaboration among multiple international regulatory authorities. According to MHRA guidance, participating partners include:

FDA (United States)
MHRA (United Kingdom)
Health Canada
Therapeutic Goods Administration (TGA) Australia
Health Sciences Authority (HSA) Singapore
Swissmedic
ANVISA Brazil

How Project Orbis Works

The programme provides a framework for concurrent submission and review of oncology applications across participating regulatory agencies. Sponsors are encouraged to submit applications to participating authorities as closely as possible to the FDA submission date.

Regulators conduct collaborative scientific discussions, share review questions, and exchange non-public regulatory information under confidentiality arrangements. This coordinated review process allows agencies to benefit from shared expertise while avoiding unnecessary duplication of effort.

Despite the collaborative review process, each regulatory authority remains responsible for making its own independent approval decision based on local legal and regulatory requirements.

Types of Project Orbis Submissions

The guidance describes three submission categories within Project Orbis:

Type A

Type A submissions involve applications submitted to participating authorities within approximately one month of FDA submission. This allows the highest level of concurrent review and may enable near-simultaneous regulatory decisions.

Type B

Type B submissions occur when applications are submitted later than one month after FDA submission but while the FDA review is still ongoing. Concurrent scientific discussions can still occur, although final decisions may not be aligned across all agencies.

Type C

Type C submissions occur after FDA regulatory action has already taken place. In these situations, participating agencies may still benefit from FDA review information, but the review process is no longer fully concurrent.

Project Orbis represents a significant shift toward more collaborative global regulatory models. As oncology drug development increasingly relies on multinational clinical trials, programmes such as Orbis help align regulatory reviews with the global nature of modern pharmaceutical innovation.