Working parties and other groups
The European Medicines Agency (EMA) has a number of working parties and related groups in place. They advise EMA's scientific committees on issues relating to their fields of expertise. EMA introduced areas of domain governance that oversee the work carried out by its working parties and related groups.
The working parties and groups provide advice on regulatory procedures that span the life-cycle of medicines. They also support the drafting of scientific guidelines.
Members of the working parties and groups are selected, based on their expertise, from the list of European experts maintained by EMA. They come from national competent authorities or academic institutions in EU and EEA Member States.
For more information:
EMA revised the way its working parties are run and structured and introduced the concept of domain governance in 2022. This ensures oversight and coordination of the different domains.
EMA's working parties are organised into five domains.
- Quality domain
- Non-clinical domain
- Methodology domain
- Clinical domain
- Veterinary domain
The role of the domains is to:
- perform strategic, tactical, operational, reactive, educational and stakeholder activities;
- produce three-year rolling strategic plans based on the priorities of EMA and of the European medicines regulatory network.
Four types of scientific group operate within these domains.
EMA's working parties are the main scientific groups advising EMA's scientific committees based on their expertise in specific scientific fields.
Three types of scientific group support the working parties:
|Operational expert groups (OEGs)||Advise on specific scientific topics and support domain-related operational activities, complementing working party expertise|
|Temporary drafting groups (tDGs)||Draft guidance documents|
|European specialised expert communities (ESECs)||Contribute to specific topics and provide expertise for the network, complementing domain-contained knowledge|
Information on EMA’s current working parties and groups is available under each EMA scientific committee:
- Co-ordination Group for Mutual Recognition & Decentralised Procedures - Human (CMDh)
- Co-ordination Group for Mutual Recognition & Decentralised Procedures - Veterinary (CMDv)