Engaging with the European Medicines Agency

Empowering Patients in the Regulatory Lifecycle of Medicines

European Medicines Agency Logo

The European Medicines Agency (EMA) plays a crucial role in the regulation and oversight of medicines within the European Union (EU). Recognizing the importance of patient involvement, the EMA actively seeks to engage patients throughout the regulatory lifecycle of medicines. By involving patients, the EMA aims to gather valuable insights, promote patient-centric decision-making, and enhance the overall safety and effectiveness of medicines. This text explores the various activities in which patients can engage and how they can actively participate in shaping the regulatory landscape.

Overview of patient involvement along the medicines lifecycle at the EMA

Patient Involvement Activities

Consultation on Medicinal Product Assessments

Patients have the opportunity to provide input during the assessment of new medicines, as well as the evaluation of existing ones. The EMA seeks patient perspectives on topics such as disease burden, treatment options, and patients’ views on potential benefits and risks. Patients can contribute through surveys, focus groups, or direct engagement with the agency.
Participation in Scientific Committees

Patients can join scientific committees or working groups within the EMA to provide their unique insights and experiences. These committees discuss various aspects of medicine regulation, such as safety, efficacy, and risk management. Patient representatives contribute by voicing patients’ perspectives, ensuring their interests are considered during decision-making processes.
Public Hearings

The EMA occasionally organizes public hearings to gather feedback on specific medicines or therapeutic areas. Patients, as well as other stakeholders, have the opportunity to express their views, concerns, and experiences related to the use of these medicines. Public hearings provide a platform for patients to directly engage with the EMA and influence regulatory decisions.
Collaborative Initiatives

Patients can participate in collaborative initiatives, including research projects, surveys, and workshops, which aim to gather patient preferences, assess treatment outcomes, and explore unmet medical needs. These initiatives enable patients to contribute their perspectives to shape the regulatory framework and improve patient access to safe and effective medicines.

How to Get Involved

Patient Organisations
Patients can engage with the EMA through patient organisations and advocacy groups. These organisations often collaborate with the EMA and act as intermediaries between patients and the regulatory authority. By joining patient organisations, individuals can access information, participate in consultations, and contribute to policy discussions.
- List of eligible patients and consumers organisations
EMA's Stakeholder Database
The EMA maintains a stakeholder database where individuals, including patients and patient representatives, can register their interest in participating in EMA activities. By signing up, individuals can receive notifications about relevant consultations, workshops, and events, ensuring they stay informed and engaged.
- Involvement in EMA activities: registration for interested individuals
- Questions and answers – EMA individual experts’ stakeholder database: patients and consumers
Calls for Patient Input

The EMA periodically issues calls for patient input on specific topics, inviting patients to provide their perspectives and experiences. These calls are published on the EMA website and other platforms. Patients can respond by sharing their insights, completing questionnaires, or participating in relevant discussions.
National Regulatory Authorities

Patients can also engage with their national regulatory authorities to voice their opinions and contribute to the regulatory process. National authorities often collaborate with the EMA and seek patient involvement at the local level. Patients can contact their national authority to inquire about opportunities for engagement.

The EMA recognizes the vital role patients play in the regulatory lifecycle of medicines. By actively engaging patients, the agency aims to ensure that regulatory decisions are informed by real-world experiences and patient needs. Patients can get involved in various activities, including consultation processes, scientific committees, public hearings, and collaborative initiatives. By participating, patients can influence decisions, contribute to the development of patient-centered policies, and ultimately enhance the safety, efficacy, and accessibility of medicines within the EU.

Interested?

Apply to the Open Academy School on Medicines Research & Development and discover how to engage with the European Medicines Agency (EMA) and actively participate in shaping the regulatory lifecycle of medicines.