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. 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 associated with the scientific evaluation of marketing authorisation applications or drafting and revision of scientific guidance documents.

Standing working parties

The current CHMP standing working parties are:

Temporary working parties

Whenever work of a temporary or an ad-hoc nature is required, the CHMP may establish a temporary working party to conduct it. The work of these parties generally involves the preparation of proposals on a specific scientific topic, the preparation of responses to specific questions raised by the CHMP, and the drafting or revision of guidelines relating to the scientific field in which the temporary working party has special competence.

The current CHMP temporary working parties are:

Drafting groups

Drafting groups are created whenever a process for reviewing or developing a particular guideline is adopted, and the topic does not fall within the remit of any of the existing working parties.

The current drafting groups are:

Scientific advisory groups

The CHMP establishes scientific advisory groups to provide advice in connection with the evaluation of specific types of medicines or treatments. They consist of European experts selected according to the particular expertise required on the basis of nominations from the CHMP or the Agency.

The current CHMP scientific advisory groups are:

Other CHMP-associated groups

Other groups are established by the CHMP to 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.

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.

Guidelines Consistency Group

A Guidelines Consistency Group has also been established. This group peer reviews all concept papers, draft guidelines and reflection papers before they are discussed at the CHMP in order to maintain regulatory and scientific consistency. The Group is composed of a few CHMP members, assessors, members from other committees and Agency staff:

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