Getting involved in EMA activities as a patient, consumer or carer
Patients, consumers and carers are involved in a wide range of European Medicines Agency (EMA) activities.
Patients, consumers and carers 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 can get involved in every aspect of the regulatory lifecycle of a medicine from pre-submission and evaluation through to post-authorisation.
They participate in committee and expert meetings and also contribute to certain types of documents.
Early dialogue in medicine development
Areas of involvement:
Orphan designation
COMP
Public summaries of orphan designation |
Advanced therapy classification
CAT
Paediatric investigation plan
PDCO
Scientific advice
SAWP
Evaluation and authorisation
Areas of involvement:
Marketing authorisation evaluation
CHMP | CAT | PRAC
Package leaflet (new) | Medicine overview |
Orphan designation maintenance
COMP
Scientific advisory / ad hoc expert groups
CHMP | PRAC
Safety monitoring of medicines
Areas of involvement:
Post marketing procedures
CHMP | CAT | PRAC
Package leaflet (renewal) | Safety communications |
Scientific advisory / ad hoc expert groups
CHMP | PRAC
Public hearings
PRAC
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:
For full details, see:
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:
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:
Patient experts contribute their clinical expertise directly into scientific regulatory discussions.
EMA contacts experts primarily via its network of eligible organisations.
Patient representatives interested in engaging with EMA can express their interest by registering to be included in EMA's individual stakeholder database via the link below.
The database’s main purpose is to identify patient representatives to participate in EMA activities and disseminate information relevant to individuals’ areas of interest.
Individuals invited to participate in EMA activities must register in EMA's experts database as ‘medicines experts’ before taking part, particularly in activities related to medicine assessment. EMA will provide instructions on how to create an account and complete the registration process.
In parallel, you can also choose to apply to EMA's open calls for remunerated external experts:
All experts involved in EMA activities must comply with the Agency’s competing interests policy.
A quick guide to competing interests is available for patients, consumers or healthcare professionals who may be involved as. It provides an overview of what is expected to be declared and the impact of the declared interests and should be read in conjunction with the policy and procedural guidance.