Patients, consumers and carers are involved in a wide range of European Medicines Agency (EMA) activities.
They are involved as either representatives of European Union (EU) patients' and consumers' organisations, representatives of their own organisation or as individual experts depending on the nature of the activity.
|Patients representing their community||Patients representing their organisation||Patients as individual experts|
Overview of patient involvement along the medicines lifecycle at EMA
Patients can get involved in every aspect of the regulatory lifecycle of a medicine from pre-submission and evaluation through to post-authorisation.
|COMP: Committee for Orphan Medicinal Products|
CAT: Committee for Advanced Therapies
PDCO: Paediatric Committee
|CHMP: Committee for Human Medicinal Products|
PRAC: Pharmacovigilance and Risk Assessment Committee
SAWP: Scientific Advice Working Party
Getting involved by representing an organisation
Any not-for-profit organisation that fulfils the following eligibility criteria is welcome to express its interest in getting involved in the work of EMA:
- legitimacy, with statutes registered in the European Union (EU);
- clear mission and objectives with an interest in medicines;
- being representative of patients or consumers throughout the EU;
- adequate structure and consultation modalities;
For full details, see:
- Criteria to be fulfilled by patient, consumer and healthcare professional organisations involved in European Medicines Agency (EMA) activities
- Assessment of patient, consumer and healthcare professional organisations' compliance with EMA eligibility criteria
Interested organisations should fill in the following application form and send it to EMA together with any supporting information. The Agency welcomes applications at any time and will send an acknowledgment of receipt after receiving the application:
- Application form for the involvement of patients' and consumer's organisations in the activities of the EMA
EMA will inform all organisations of the outcome of the evaluation of their application. EMA publishes information on eligible organisations on Eligible patients' and consumers' organisations.
Please note that eligibility is re-assessed annually. For more information, see:
Getting involved as an individual expert
Patient experts contribute their real-life experience of living with their condition directly into scientific regulatory discussions.
EMA contacts experts primarily via its network of eligible organisations. However, individuals interested in working with EMA can also be included in the individuals’ stakeholder database, by completing the online registration form:
For more information on the database, see:
- EMA’s individual stakeholder database: patients, consumers, healthcare professionals and academia - Frequently asked questions
Forms prior to involvement
All experts, including patient and consumer representatives, need to complete certain forms before they can be involved in specific EMA activities, in particular those related to the assessment of medicines. These forms include the:
- declaration-of-interests and confidentiality-agreement form: EMA has a robust conflicts of interests policy to ensure that experts participating in the Agency's activities have no interests in the pharmaceutical industry that could affect their impartiality. As part of this policy, all patient and consumer representatives working with the Agency must complete a public declaration of interests and confidentiality form.
- expert-nomination form and e-curriculum vitae (e-CV): All experts need to complete a nomination form and electronic curriculum vitae.
For more information and guidance on filling in the forms, see: