Healthcare professionals
The European Medicines Agency (EMA) has been interacting with European healthcare professionals in various areas of its work since it was founded in 1995.
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As prescribers and handlers of the medicines that the Agency evaluates, healthcare professionals are key stakeholders in the Agency's work and have specific knowledge and expertise to offer. The Agency is committed to maintaining a strong working relationship with this group.
Key milestones of EMA interaction with healthcare professionals (HCPs)
- 1995: EMA created
- 1996: HCPs as members of scientific committees
- 2004: Doctors' representative joins EMA Management Board
- 2006: Working group with HCP organisations created
- 2011: Framework of interaction with HCPs and their organisations
- 2013: Healthcare Professionals Working Party
- 2019: Strengthened collaboration with general practitioners
- 2020: HCPs engagement in crisis management
- Ongoing: Clinical experience systematically included in regulatory output
Framework for interaction
Ten years of structured interaction
December 2021 marked ten years of cooperation between EMA and healthcare professionals under a formal framework for interaction.
A report summarises the experience, including:
- type of organisations that EMA has been interacting with;
- steps that led to the framework;
- key milestones;
- direction for future interactions.
EMA is committed to working closely with its expanding network of healthcare professional organisations and encourages all eligible, not-for-profit organisations to get involved.
The framework describes the objectives and the terms of reference for this interaction and aims to:
- support the Agency in accessing the best independent expertise in any matter related to medicines;
- contribute to more efficient and targeted communication to healthcare professionals;
- enhance understanding of the role of the EU medicines regulatory network.
The framework is in line with EMA's overarching framework for stakeholder relations management.
It was first endorsed by EMA’s Management Board in December 2011 and revised in 2016.
More information:
Collaboration with general practitioners
EMA and the two major organisations representing general practitioners (GPs) and family physicians in Europe – the European Union of General Practitioners (UEMO) and the European section of the World Organization of Family Doctors (WONCA) – and the major organisation representing primary care professionals in Europe, the European Forum for Primary Care (EFPC), have signed a joint statement committing to strengthening interactions:
It contains an action plan until 2020, which includes involving GPs and family physicians in EMA evaluations, developing relevant communication activities and exploring further collaboration with research networks in primary care, with a focus on generating real-world evidence. It also identifies opportunities for cooperation in regulatory science training.
Activities of healthcare professionals
Healthcare professionals are involved in a wide range of activities at the Agency, including:
- as members of the Management Board;
- as members of its scientific committees;
- responding to specific requests from the Agency's scientific committees and working parties;
- taking part in discussions on the development and authorisation of medicines;
- reviewing written information on medicines prepared by the Agency;
- being involved in the preparation of guidelines;
- taking part in Agency conferences and workshops.
Stakeholder engagement report
EMA publishes an annual report on its interactions with patients, consumers, healthcare professionals, academics and their organisations, incorporating both quantitative and qualitative data.
For previous reports, see Key documents.
Read 2022-2023 stakeholder engagement report
Input towards revision of 'ICH E6 Good clinical practice guideline'
EMA is helping ICH to ensure that the perspectives of European patients, healthcare professionals and clinical researchers are taken into account in the ongoing revision of its International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 good clinical practice (GCP) guideline, by coordinating the stakeholder engagement process in Europe on the behalf of ICH.
As a first step, EMA held a workshop with its Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties in June 2020 to gather their views and experiences. The workshop summary report is available:
ICH is revising this guideline to make it more responsive to advances in clinical trial design and conduct. It has committed itself to engaging stakeholders from the outset of the revision process, particularly patient representatives and academic clinical researchers. This is to ensure that the revised guideline will meet the needs of those conducting or participating in clinical trials.
For more information on the ICH E6 revision process, see:
Human Medicines Highlights is an EMA monthly newsletter aimed at patients, consumers and healthcare professionals.
It contains updates on medicines regulation and news for stakeholders.
Issues from May 2024 (Issue 180) onwards are available at the link below:
Previous issues 118-179 are available on EMA's website in PDF format:
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