CHMP: Working parties and other groups
The Committee for Medicinal Products for Human Use (CHMP) establishes a number of working parties at the beginning of each three-year mandate. Most working parties operate under the governance of a domain. These working parties have expertise in a particular scientific field, and are composed of members selected from the list of European experts maintained by the Agency.
The CHMP consults its working parties on scientific issues relating to their particular field of expertise, and delegates certain tasks to them in the context of the scientific evaluation of marketing authorisation applications or drafting and revision of scientific guidance documents.
Working parties can be supported by operational expert groups (OEGs), temporary drafting groups (tDGs) and European specialised expert communities (ESECs).
For more information, see:
The majority of working parties and related groups operate under the governance of a domain, as follows:
Quality domain
Working parties:
- Biologics Working Party (BWP)
- Biosimilar Medicinal Products Working Party (BMWP)
- Quality Working Party (QWP)
Operational expert groups:
Non-clinical domain
Working parties:
Operational expert groups:
European specialised expert communities:
Methodology domain
Working parties:
Clinical domain
Working parties:
- Cardiovascular Working Party (CVSWP)
- Central Nervous System Working Party (CNSWP)
- Haematology Working Party (HAEMWP)
- Infectious Diseases Working Party (IDWP)
- Oncology Working Party (ONCWP)
- Rheumatology/Immunology Working Party
- Vaccines Working Party (VWP)
Operational expert groups:
- Scientific Advisory Group on Cardiovascular Issues
- Scientific Advisory Group on Infectious Diseases
- Scientific Advisory Group on Neurology
- Scientific Advisory Group on Vaccines
- Inter-Committee Scientific Advisory Group on Oncology
European specialised expert communities:
These groups provide expertise in their respective areas. The CHMP consults these groups and delegates to them certain tasks associated with marketing authorisations, applications, and the drafting and revision of guidance documents.
- Active Substance Master File Working Group
- Geriatric Expert Group
- Guidelines Consistency Group
- Healthcare Professionals Working Party (HCPWP)
- (Invented) Name Review Group
- Patients' and Consumers' Working Party (PCWP)
- Working Group on Quality Review of Documents
- Scientifc Advice Working Party (SAWP)
- Summary of Product Characteristics Advisory Group
The CHMP is further supported by the work of the good manufacturing practice (GMP), good clinical practice (GCP) and good laboratory practice (GLP) inspection services groups. Information on their role is available under Compliance: Overview.
The following working parties and other groups have been retired and are no longer constituted:
- Gastroenterology Drafting Group
- Respiratory Drafting Group
- Radiopharmaceutical Drafting Group
Recently established working parties and other associated groups have taken over certain activities of retired working parties and other groups, as follows:
- Methodology Working Party (MWP) - for the retired Biostatistics Working Party (BSWP), Modelling and Simulation Working Group (MSWG), Pharmacogenomics Working Party (PGWP) and Pharmacokinetics Working Party (PKWP)
- Non-clinical Working Party (NcWP) - for the retired Safety Working Party (SWP), Non-clinical Working Group (NcWG) and Excipients Drafting Group (ExcpDG)
- 3Rs Working Party (3RsWP) - for the retired Expert Group on 3Rs
- Oncology European Specialised Expert Community - for the retired Radiopharmaceutical Drafting Group