ACT EU aims to transform how clinical trials are initiated, designed and run to further promote the development of high quality, safe and effective medicines, and to better integrate clinical research in the European health system.

The initiative seeks to deliver on the clinical trial innovation recommendations of the European medicines agencies network strategy and the European Commission’s Pharmaceutical strategy for Europe.

It builds on the Clinical Trials Regulation (CTR) and Clinical Trials Information System's (CTIS) launch on 31 January 2022.

The European Commission, EMA and Heads of Medicines Agencies (HMA) launched ACT EU in January 2022.

For more information, see the ACT EU website:

Workplan

The ACT EU workplan sets out deliverables and timelines for the programme for 2022-26.

The deliverables for 2023 include the following:

  • Establishing a process to support academic sponsors in enabling large multinational clinical trials
  • Supporting clinical trial sponsors to make best use of available CTIS and CTR training activities
  • Setting up a multi-stakeholder platform to facilitate dialogue between clinical trial stakeholders, including patients, healthcare professionals and academia
  • Modernising good clinical practice by supporting the adoption and implementation of revised EU guidelines in clinical trial design
  • Facilitating innovation in clinical trial methods by publishing a methodology roadmap and further developing guidance on decentralised clinical trials

EMA, the European Commision and the Heads of Medicines Agencies (HMA) published the workplan in August 2022.

ACT EU multi-annual workplan 2022-2026

Priority actions

The programme's strategy paper features ten priority action (PA) areas that are the basis for the ACT EU workplan.

The PAs are listed and detailed below.

Accelerating clinical trials in the EU (ACT EU) - Delivering an EU clinical trials transformation initiative

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.

A public consultation on the CTIS transparency rules was open from 3 May to 28 June 2023. EMA is currently reviewing the comments received, with the aim of publishing a concept paper with the proposed simplified transparency rules later this year. 

Related guidance is available, taking into account feedback received during a public consultation concluded in 2022: 

To find out more, see:

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:

The survey was conducted in 2022.

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:

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

The report on the outcome of this public consultation is now available:

For more information:

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 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:

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:

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:

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:

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: 

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 decentralised clinical trials

A reflection paper on single-arm clinical trials submitted as pivotal evidence in a marketing authorisation application is available for public consultation until 30 September 2023.

ACT EU PA08 multi-stakeholder methodology workshop will take place 23 November.

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: 

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. 

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:

EMA published this strategy in February 2022.

For more information, see the ACT EU workplan.

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