Mapping & governance

European Commission, Lead DG: SANTE – DG Health and Food Safety*

Article 85 of the Clinical Trials Regulation (EU) 536/2014 (“CTR”)

To contribute to the implementation of the CTR, including its implementing acts.

• To represent the view of their Member State in the context of the CTR;  ensuring appropriate coordination between the organisations involved in the implementation of the CTR in their Member State, including but not limited to the national competent authorities and ethics committees;
• To support the exchange of information between the Member States and the Commission on the experience acquired with regard to the implementation of this Regulation.

• Register of Commission expert groups and other similar entities (europa.eu)
• CTAG rules of procedure

Heads of Medicines Agencies working group

To contribute to increasing the attractiveness of the EU/EEA for clinical trials by promoting harmonisation and optimisation of the regulatory environment while assuring the protection of rights, safety and wellbeing of participants and the generation of robust data.

See CTCG mandate and rules of procedure

Heads of Medicines Agencies: Clinical Trials Coordination Group (hma.eu)

Subgroup under CTCG

Weekly, with individual topics covered once per month (pre-clinical, clinical, quality and part II related topics) with separate meetings for scientific advice.

Once a month, members from ethics committees are invited to join, if not already participating.

To discuss regulatory and scientific issues arising during the assessment of clinical trials, to discuss solutions, drive consistency of approaches across Member States and to provide training.

Discuss solutions to questions raised by sponsors and MSs to drive harmonised approaches across NCAs and ethics committees.

Special group under the European Commission, Support DG: SANTE – DG Health and Food Safety*, led by MedEthicsEU board.

Monthly and ad-hoc when necessary

To strengthen collaboration between the medical research ethics committees reviewing clinical trials applications falling under the Clinical Trials Regulation (CTR), performance study applications falling under the In Vitro Diagnostics Regulation (IVDR) and clinical investigation applications falling under Medical Device Regulation (MDR) in the EU/EEA Member States.

• Provide a forum for discussion and mutual learning;

• Align and promote harmonisation on operational procedures;

• Establish cooperation regarding research ethics matters with relevant European level entities in the field of clinical research, in particular, CTAG, EMA, the Clinical Investigation subgroup (CIE) and the In Vitro Diagnostics subgroup (IVD) of the Medical Device Coordination Group (MDCG), but also CTCG and the European Network of Research Ethics Committees (EUREC).

Heads of Medicines Agencies (HMA) voluntary discussion forum

• Scientific Advice Working Party (SAWP);
• EU Innovation Network (EU-IN);
• Clinical Trials Coordination Group (CTCG);
• The European Network of Health Technology Assessment (EUnetHTA);
• Innovation Task Force (ITF) and Small and medium-size enterprise (SME) office at EMA.

The Steering group consists of co-chairs of the groups involved to enhance the communication between the group. The chair is provided by the HMA.

To enhance the dialogue and communication between the groups giving scientific and/or regulatory advice to innovators; to set the strategy and vision for collaboration and plan the group’s annual meetings.

Heads of Medicines Agencies

Article 57(1)(i) of Regulation (EC) No 726/2004

Representatives of the good clinical practice (GCP) inspectorates of the European Economic Area Member States, and the EMA Inspections Office. Observers from the European Commission, the World Health Organisation, Swissmedic and EU enlargement countries.

The chair is provided by the EMA Inspections office.

To promote harmonisation and co-ordination of GCP related activities at community level to discuss and align positions in relation to compliance issues.

• To prepare new and revised guidance on GCP and community procedures relating to inspection;
• To support the co-ordination of the provision of GCP advice and provides a link with other groups such as CHMP, CVMP, EWP and PhVWP;
• To maintain a dialogue with GMP inspectors on areas of common interest in particular the interface between good manufacturing practice (GMP) for investigational medicinal products and GCP.

Good Clinical Practice Inspectors Working Group | European Medicines Agency (europa.eu)

Initiative co-led by the European Commission, Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA).

The Steering Group reports to the EMA Management Board and HMA.

To accelerate clinical trials in the EU/EEA by creating a favourable environment for clinical research. 

• Decision-making body 
• To oversee the ACT EU programme management structure.
• To monitor the progress of the projects through the adoption of multi-annual workplans.  
• Identify and discuss critical issues related to the broad environment of clinical research.

Working group of European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) 

To facilitate the development of innovative medicines and technologies for drug development including innovative unprecedented concepts of clinical trial design and methodologies by addressing gaps in early regulatory support to innovation.

• Driving and supporting the EU innovation ecosystem;
• Implementing and delivering on the EU innovation strategies (European Medicines Agencies Network Strategy, EMA Regulatory Science Strategy, EU Pharmaceutical Strategy);
• Making the regulatory support available at national and EU level more visible and attractive to innovators from an early stage;
• Horizon scanning to identify emerging trends in science and technology that are relevant to medical research and development;
• Responsible for discussing and sharing non-binding opinions on borderline classification issues;
• Contributing to the HMA/EMA repurposing pilot in the pre-entry phase;
• Managing the Simultaneous National Scientific Advice (SNSA) pilot to facilitate clinical trials and other areas where national scientific advice may be sought in parallel from different NCAs;
• Encouraging and facilitating competent authorities' involvement in relevant EU-funded projects.

EU Innovation Network (EU-IN) | European Medicines Agency (europa.eu)

Standing working party established by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

To optimise research and development, reduce uncertainties in regulatory outcomes, and accelerate time to approval of a marketing authorisation application.

SAWP coordinates the provision of scientific advice and protocol assistance. It brings an integrated view forward to the CHMP and the COMP on:

• quality relating to the development of medicinal products;
• non-clinical and clinical safety and efficacy relating to the development of medicinal products;
• the significant benefit of orphan medicinal products.

Working party of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)

To leverage cross-disciplinary expertise to support methodological innovation in global drug development, and support advice and interpretation of complex methodology across (clinical) drug development.

• Provide product-related support when requested by EMA Committees and the Scientific Advice Working Party;
• Engage with stakeholders;
• Prepare, review and update guidelines and concept papers;
• Provide training and workshops to assessors.

Methodology Working Party | European Medicines Agency (europa.eu)

EMA multidisciplinary horizontal cross-sectorial group

ITF members are scientific and legal administrators appointed from all areas of the EMA.

To provide early scientific, legal and regulatory support to global innovative medicine developments intended for the EU market/ regulatory system with a particular focus on emerging therapies and technologies.

Preparatory early entry door for innovation in medicines.

• Provide a multidisciplinary platform for early informal dialogue with applicants of emerging therapies and technologies;
• Provide scientific opinion to applicants on the eligibility for access to EMA procedures;
• Exchange information and establish networks both internally and externally to develop and maintain overall network expertise in new fields;
• Identify areas for legal, regulatory and technical guidance preparation.

Supporting innovation | European Medicines Agency (europa.eu)

Established by EMA in accordance with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123).

The ETF took over the activities of the COVID-19 EMA Pandemic Task Force that EMA convened in March 2020 to address the COVID-19 pandemic. 

• Representatives of EMA's committees and working parties, including its Patients’ and Consumers’ Working Party (PCWP) and Healthcare Professionals’ Working Party (HCPWP);
• Representatives of EMA;
• Representatives of the Clinical Trials Coordination and Advisory Group (CTAG);
• Clinical-trial experts from the national competent authorities.

To ensure that high quality, safe and efficacious medicinal products, which have the potential to address public health emergencies, can be developed and made available within the European Union as soon as possible during public health emergencies.

• Providing scientific advice on the development of treatments and vaccines and on clinical trial protocols;
• Reviewing scientific data;
• Engaging in preliminary discussions on how to best develop medicines for public health emergencies;
• Supporting EMA's scientific committees to evaluate applications for authorisation and monitoring  safety;
• Providing scientific recommendations on the use of medicines prior to their authorisation;
• Making best use of real-world evidence to support preparation for crises and responding to them;
• Cooperating with stakeholders, and European and international organisations.

The CTIS Forum was formed after the go live of the Clinical Trials Regulation (EU) No. 536/2014 in 2022.

To allow direct exchanges of information, to discuss user experiences and to inform about CTIS operations and delivery, training and communication as well as other relevant topics in the context of CTIS. 

Established as part of the ACT EU initiative co-led by European Commission, Heads of Medicines Agencies and European Medicines Agency.

The MSP AG reports to the ACT EU Steering Group.

Representatives of:

• Patients/consumers: 5 selected from relevant organisations, including the Patient and Consumer Working Party;
• Healthcare professionals: 4 selected from relevant organisations, including the Healthcare Professional Working Party;
• Pharmaceutical industry EU trade organisations: 4 selected from relevant organisations;
• Non-commercial European clinical data and translational research organisations and networks: 4 selected from relevant organisations;
• Research funders: 4 selected from relevant organisations.

Two ethics committee representatives and ACT EU regulatory partners, actively participate in the meetings.

The MSP AG brings together key stakeholder groups who are directly impacted by clinical trial-related activities in the EU to increase collaboration, build mutual trust and with the ultimate goal of improving the EU clinical trials landscape. 

The MSP AG provides insight into the perspectives and needs of the different stakeholder groups and allows stakeholders to provide strategic and operational advice regarding ACT EU.

• To provide the ACT EU Steering Group with their views and strategic advice on the ACT EU  multi-annual workplan;
• To identify stakeholder needs, concerns, challenges and priorities, and communicating these to the ACT EU regulatory partners;
• To advise ACT EU regulatory partners on stakeholder engagement and communication;
• To review and agree on the mandate, workplan and any governance-related documents of the advisory group;
• To keep their respective stakeholder group informed of the output from ACT EU MSP initiatives and overall ACT EU activities.