---
title: "Launch of the first phase of the COMBINE Project 1 pilot - \"all-in-one” coordinated assessment"
description: "On 13 June 2025, the European Commission, together with EU Member States and the European Medicines Agency (EMA), launched the first phase of the COMBINE Project 1 pilot—a one-stop, coordinated assessment process for combined clinical trials of medicines and performance studies of companion in vitro diagnostic (IVD) devices."
url: https://qbdgroup.com/en/regulatory-updates/combine-project-1-pilot
type: "Regulatory update"
language: en
published: 2025-06-23
author: "Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD"
category: "Regulatory Affairs"
publisher: "QbD Group"
citation: "QbD Group, \"Launch of the first phase of the COMBINE Project 1 pilot - \"all-in-one” coordinated assessment\", https://qbdgroup.com/en/regulatory-updates/combine-project-1-pilot"
---
# Launch of the first phase of the COMBINE Project 1 pilot - "all-in-one” coordinated assessment
> On 13 June 2025, the European Commission, together with EU Member States and the European Medicines Agency (EMA), launched the first phase of the COMBINE Project 1 pilot—a one-stop, coordinated assessment process for combined clinical trials of medicines and performance studies of companion in vitro diagnostic (IVD) devices.

Sponsors can now submit a single application for trials involving both a medicinal product and its companion diagnostic, across multiple EU countries.

The pilot aims to streamline authorisation timelines, reduce duplication, enhance transparency, and apply harmonised evaluations across participating Member States.

Expressions of interest are open until 31 August 2025; selected sponsors will be notified by 31 October.

[Learn more on the European Commission website](https://health.ec.europa.eu/medical-devices-topics-interest/combined-studies/combine-project-1-pilot-all-one-coordinated-assessment_en)

## What does this mean to you?

If you're active in **pharma or IVDs**, this pilot could drastically **simplify the authorisation process**: fewer submissions, less administrative burden, and quicker approvals of combined studies.

For clinical researchers and device sponsors, this means **faster patient access** to innovative treatments and **greater regulatory efficiency** across EU borders.

If you’re considering a combined study, now is the time to act. **As your Legal Representative, we can help you prepare your submission, coordinate with the authorities, and support your response to the call for interest before the 31 August deadline.**

Reach out today to explore how we can assist you in making the most of this opportunity.

[![CTA RA update](https://no-cache.hubspot.com/cta/default/7030766/interactive-184700193895.png)](https://qbdgroup.com/hs/cta/wi/redirect?encryptedPayload=AVxigLIdBQMPKKSlhMJ4ziIyOg2%2FAawo2ZherOLf3AbZk%2F50IHk4olhg56pXZKdtQE4TjIl%2ByVG44KN%2BrmVuRqUOds8pRbnMBouSRg0s8I0mHwhT0RG%2B79owwSBx3MmW6PApzE1tmGZBdWBuTqQtHCWjZWy5fwRyhjpIk4c4crm96Ybh4wOCnNh8n%2FtJnmDB6GIVOIDXbWW%2FB8BebCMipBMmG9ChZg%3D%3D&webInteractiveContentId=184700193895&portalId=7030766)
---
Source: https://qbdgroup.com/en/regulatory-updates/combine-project-1-pilot — © QbD Group. Quote freely with attribution and a link back.