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.

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.

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.

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.

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

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

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.

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.