EU: Two New Advisory Pilots to Enhance Clinical Trials in Europe
The Accelerating Clinical Trials in the EU (ACT EU) initiative has launched two pilots to improve clinical trial applications, crucial for developing safe and effective medicines in Europe. ACT EU, a collaboration between the European Medicines Agency (EMA), Heads of Medicines Agencies (HMA), and the European Commission (EC), aims to transform clinical trial processes.
- The first pilot provides scientific advice on clinical trials and marketing authorisation applications (MAA). For the first time, the EMA's Scientific Advice Working Party (SAWP) and the HMA's Clinical Trials Coordination Group (CTCG) will jointly assess these requests to reduce inconsistencies.
- The second pilot, coordinated by the CTCG, offers technical and regulatory support on clinical trial applications (CTA) before submission. This pilot consolidates Member States' views on pre-submission topics, covering areas like regulatory aspects of low interventional trials and complex trial designs.
Starting today, developers can apply for these pilots to receive advice on MAA or CTA requirements. The pilots' duration will be evaluated based on collected data and feedback, guiding future optimizations in clinical trial support.
Two guidance documents accompany the pilots, providing further support for clinical trial application submissions. The summaries of these guidances are provided below.
| Guidance Documents | Summary |
| What is the pre-CTA advice pilot? | The pre-CTA advice pilot is an advice to applicants who are planning to submit a clinical trial application (CTA) to the clinical trial information system (CTIS) under the Regulation (EU) No 536/2014. For the pre-CTA advice there will be coordination between assessors from National Competent Authorities of the EU Member States on regulatory and technical aspects of clinical trials. |
| What is the SAWP-CTCG pilot? | The SAWP-CTCG pilot is a scientific advice pilot offered as part of the ACT-EU Priority Action on consolidated advice. The pilot provides advice on scientific aspects of clinical trials towards clarification of both clinical trial and marketing authorisation application requirements via the increased collaboration between the European Medicine Agency’s Scientific Advice Working Party (SAWP) and the Clinical Trial Coordination Group (CTCG), Member States and National Competent Authorities. The pilot enhances coordination of advice activities on clinical trial and development program design within the European Medicines Regulatory Network (EMRN), to facilitate the development of safe and effective medicines for human use. |
Pilots are part of the ACT EU collaboration to foster high-quality clinical research in the EU, impacting Gilead/Kite's clinical trials and regulatory submissions in the region.
Guidance for applicants: pre-CTA advice pilot
Guidance for applicants: SAWP CTCG pilot on scientific advice