Accelerating Clinical Trials in the EU (ACT EU)

The priority action refers to mapping existing clinical trial activities and developing a governance rationalisation strategy. 

This aims to clarify the roles and responsibilities of the various expert groups working within the European medicines regulatory network.

For more information, see the ACT EU workplan.

The priority action aims to oversee the successful and timely implementation of the Clinical Trials Regulation (CTR) and its implementing acts.

This includes aspects such as: 

• tracking the performance of the European clinical trials environment; 
• raising awareness of training;
• addressing implementation issues in a swift manner.

For more information, see the ACT EU workplan.

Under ACT EU, the European medicines regulatory network publishes statistics on the authorisation of clinical trials in the EU / EEA every month. This information provides an insight into how the CTR is transforming clinical trials.

A report is available summarising the findings of a survey for sponsors who submitted trials under the CTR:

• Summary report on targeted consultation on the implementation of the Clinical Trials Regulation (EU) No 536/2014

The survey was conducted in 2022.

Guidance is also available for CTIS users on how to protect personal data and comercially confidential information:

• Q&A on the protection of commercially confidential information and personal data while using CTIS

To find out more, see:

• Clinical Trials Regulation: progress on implementation

This priority action aims to establish a platform for stakeholders involved in designing, regulating, performing and participating in clinical trials.

It should help identify relevant scientific, methodological and technological advances to develop the clinical trials environment in the EU.

A concept paper is available on the importance of engaging stakeholders in all phases of a clinical trial, including trial design, and the objectives, composition, governance and transparency rules for the multi-stakeholder platform:

• ACT EU multi-stakeholder platform concept paper 

EMA invited stakeholders to provide input on these areas, priority topics for the multi-stakeholder platform and to express their interest in participating.

For more information, see the ACT EU workplan.

The priority action is meant to support the modernisation of good clinical practice in order to align with the increasingly diverse range of clinical trial types and data sources. 

This will support the implementation of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 guideline.

For more information, see the ACT EU workplan.

The priority action intends to maximise the value of clinical trials data to support evidence-based decision-making.

It aims to enable the development of a publicly accessible EU clinical trials dashboard.

For more information, see the ACT EU workplan.

The priority action aims to plan and launch a targeted communication campaign to engage all stakeholders who enable clinical trials.

They include data protection experts, academia, small and medium-sized enterprises (SMEs), funders, health technology assessment (HTA) bodies and healthcare professionals.

For more information, see:

• ACT EU workplan
• Clinical trials highlights

The priority action aims to reinforce scientific advice coordination between clinical trial approval and clinical trial design, so as to facilitate the development of safe and effective medicines.

This will further foster collaboration between EMA's Agency's Scientific Advice Working Party (SAWP) or Emergency Task Force (ETF), on one side, and the HMA's Clinical Trial Coordination Group (CTCG) on the other side.

The project will include a number of pilot phases planned until the end of 2025.

For more information, see the ACT EU workplan.

In order to clarify the scope of scientific advice activities, ACT EU mapped information on voluntary procedures available within the European medicines regulatory network:

• Science advice on medicines for human use in the EU medicines regulatory network

The programme also collated updates on other scientific advice procedures, as shown below.

EMA centralised scientific advice

For scientific advice provided by SAWP and the Committee for Medicinal Products for Human Use (CHMP), EMA clarifies which questions are outside the scope through the following resources:

• Scientific advice and protocol assistance: Questions outside the scope of scientific advice
• European Medicines Agency Guidance for Applicants 
  seeking scientific advice and protocol assistance (clean version)
• European Medicines Agency Guidance for Applicants seeking scientific advice and protocol assistance (version with track changes)

EMA centralised scientific advice for public health emergencies

EMA's ETF and CHMP also provide centralised scienfic advice for medicines targeting a declared or potential public health emergency, and for preparedness, based on articles 15 and 16 of Regulation 123/2022.

For related guidance for developers, see:

• COVID-19 guidance: research and development
• Scientific advice and protocol assistance: Medicines intended for a disease causing public health emergency

Simultaneous national scientific advice (SNSA)

The EU Innovation Network (EU IN) consulted ACT EU to launch the second phase of its pilot on simultaneous national scientific advice (SNSA). The launch took place in November 2022.

For more information on SNSA's purpose, and to access relevant documents such as guidance and application forms, see: 

• Heads of Medicines Agency: Simultaneous national scientific advice (SNSA) pilot phase 2 launch
• Innovation in medicines: EU Innovation Network - Simultaneous national scientific advice

The SNSA pilot focuses specifically on scientific advice to facilitate clinical trials within the EU.

The optimised SNSA process will continue to complement and provide a bridge between purely national scientific advice and centralised European scientific advice procedures from EMA.

The pilot is expected to inform the development of a final consolidated process for the provision of clinical trial-related advice.

This priority action aims to develop and publish guidance on key methodologies. 

This will ensure that all relevant EU expert groups pool their expertise and align their priorities in order to accelerate the development of future guidance, in collaboration with relevant stakeholders.

Guidance is already available for complex clinical trials, and due by the end of 2022 for decentralised clinical trials. 

For more information, see the ACT EU workplan.

The priority action aims to successfully establish clinical trials safety monitoring in the EU. 

This would see Member States working together to improve trial safety through coordinated work-sharing assessment, in line with the EU4Health Joint Action.

To support these activities this priority action will focus on training for safety assessors, with the development of a curriculum to harmonise expertise.

It will also enable the implementation of ICH E19 guideline on selective safety data collection. 

For more information: 

• ACT EU workplan
• Risk proportionate approaches in clinical trials: Recommendations of the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use

The priority action aims to provide a training curriculum informed by regulatory experience, with modules on drug development and regulatory science.

This curriculum is expected to engage universities and SMEs, and serve as an educational ecosystem. 

Update: A training strategy is available, setting out high-level objectives for the development of a training curriculum.

This document highlights the importance of accessing appropriate expertise in medicines development:

• ACT EU training strategy

EMA published this strategy in February 2022.

For more information, see the ACT EU workplan.