Getting involved in EMA activities as a patient, consumer or career

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.

• Representing their community:
  • Management Board
  • Scientific Committee(s)
• Representing their organisation:
  • Patients' and Consumers' Working Party (PCWP)
  • EMA consultations
  • Workshops
• As individual experts:
  • Scientific advice / protocol assistance procedures
  • Scientific advisory / ad hoc expert groups
  • Scientific committee consultations
  • Review of documents

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.

They participate in committee and expert meetings and also contribute to certain types of documents.

Lifecycle overview of involvement in meetings and outputs

1. 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

2. 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  

3. 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   

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;
• transparency.

For full details, see:

Criteria to be fulfilled by patient, consumer and healthcare professional organisations involved in European Medicines Agency (EMA) activities

Reference Number: EMA/MB/24913/2005 Rev.3

Assessment of patient, consumer and healthcare professional organisations’ compliance with EMA eligibility criteria

Reference Number: EMA/698917/2017

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 consumers’ organisations in the activities of the European Medicines Agency

Reference Number: EMA/520442/2010 Rev. 6

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:

• Webinar for annual confirmation of eligibility

Sample eligibility form - Patients and consumers

Getting involved as an individual expert

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 acitivities 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:

• Procurement: Calls for external experts

All experts involved in EMA activities must comply with the Agency’s competing interests policy.

Get involved in EMA activities

Patients representatives can register to be included in EMA's individual stakeholder database and participate in activities related to medicine development and evaluation. More information is available in the FAQs below.

Register as individual expert

EMA’s individual stakeholder database: patients, consumers, healthcare professionals and academia - Frequently asked questions

Reference Number: EMA/441045/2016 Rev.2