Highlights
- What is the pre-CTA advice pilot?
- What is involved in the process?
- What are the eligibility criteria for the pre-CTA advice pilot?
- What is the scope for the pre-CTA advice pilot?
- How to apply
What is the Pre-CTA advice pilot?
In June 2024, the Accelerating Clinical Trials in the EU (ACT EU) initiative rolled out a new pilot program to enhance the quality of applications for clinical trial authorisation (CTAs).
ACT EU is a collaborative effort, involving the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) in EU Member States, and the European Commission (EC). Their mission is to streamline how clinical trials are initiated, designed, and conducted in the EU – thereby supporting the development of safe and effective medicines.1
Overseen by the Clinical Trials Coordination Group (CTCG), this pilot offers technical and regulatory support on CTAs, before submission through the Clinical Trials Information System (CTIS). Unlike before, where support was only available nationally, this pilot provides a consolidated view from multiple Member States, covering various topics such as de-centralised trials and complex trial designs.1
Developers can apply now to this pilot for guidance on CTAs. The effectiveness of these programs will be continuously evaluated, and the feedback gathered will help shape future clinical trial support strategies in Europe.
These pilots hope to strengthen the European medicines regulatory network by boosting the quality of clinical trial applications, ultimately enhancing the development of new, high-quality medicines.
Frequently asked questions
What is involved in the process?
What are the eligibility criteria for the pre-CTA advice pilot?
- Applicants can ask up to five regulatory and technical questions per pre-CTA advice request.
- The protocol must be mature and almost complete.
- Applicants should know the proposed reporting member state for the CTA in CTIS.
What is in the scope of the pre-CTA advice pilot?
- Clinical trials that fall under the clinical trial regulation,
- Combination products, medical devices, in vitro medical devices,
- Operational, regulatory, and technical aspects of the CTA in CTIS,
- Requests related to a re-submission of an updated dossier,
- Good laboratory practice regulatory requests, and
- Decentralised clinical trial requests.
What is out of scope?
- Requests regarding scientific aspects of clinical trials.
- CTA preassessment.
How to apply for pre-CTA advice
Apply via email, using the dedicated application form.
State that you are requesting to be admitted to the pre-CTA advice pilot and include the proposed reporting member state (RMS) for the application.
Summary
The rollout of the pre-CTA advice programme is a collaborative effort by multiple regulatory stakeholders, aiming to improve the quality of clinical trial applications and marketing authorisation applications.
This is an important and timely initiative to support CTA submissions via CTIS. Offering enhanced guidance to applicants running clinical trials in Europe will be beneficial in streamlining the CTA process to develop safe and efficacious medicines for patients.
How Somerville Development Partners can help
We have decades of experience preparing for and attending scientific advice meetings throughout Europe, including national and centralised advice.
We will work with you to identify which aspects of your development plan require advice from the regulatory agency, and at which point in development.
We will:
- Provide expert advice on regulatory requirements,
- guide you through the application process,
- arrange and attend scientific advice meetings,
- draft any briefing documents,
- manage the operational aspects of the submission,
- respond to validation/review comments, and
