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:
In this section
- CHMP: Working parties and other groups
- CVMP: Working parties and other groups
- COMP: Working parties and other groups
- HMPC: Working parties and other groups
- CAT: Working parties and other groups
- PDCO: Working parties and other groups
- Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)
- Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (CMDv)
- Emergency Task Force (ETF)
- EU Innovation Network (EU-IN)
- EudraVigilance Expert Working Group
- Medicine Shortages Single Point of Contact (SPOC) Working Party
- Medical Device Shortages Single Point of Contact (SPOC) Working Party
- Signal Management Review Technical (SMART) Working Group
Overview and domains
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:
Group | Function |
---|---|
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Temporary drafting groups (tDGs) | Draft guidance documents |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 |
EMA working parties
Information on EMA’s current working parties and groups is available under each EMA scientific committee: