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:
- Healthcare Professionals' Working Party
- Biologics Working Party
- Patients' and Consumers' Working Party
- Quality Working Party
- Safety Working Party
- Scientific Advice Working Party
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:
- Biosimilar Medicinal Products Working Party
- Biostatistics Working Party
- Blood Products Working Party
- Cardiovascular Working Party
- Central Nervous System Working Party
- Infectious Diseases Working Party
- Oncology Working Party
- Pharmacogenomics Working Party
- Pharmacokinetics Working Party
- Rheumatology/Immunology Working Party
- Vaccines Working Party
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:
- Excipients Drafting Group
- Gastroenterology Drafting Group
- Radiopharmaceuticals Drafting Group
- Respiratory Drafting Group
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:
- Scientific Advisory Group on Cardiovascular Issues
- Scientific Advisory Group on Anti-infectives
- Scientific Advisory Group on Diabetes/Endocrinology
- Scientific Advisory Group on HIV / Viral Diseases
- Scientific Advisory Group on Neurology
- Inter-Committee Scientific Advisory Group on Oncology
- Scientific Advisory Group on Psychiatry
- Scientific Advisory Group on Vaccines
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.
- (Invented) Name Review Group
- Working Group on Quality Review of Documents
- Expert Group on the Application of the 3Rs in the Development of Medicinal Products
- Active Substance Master File Working Group
- Geriatric Expert Group
- Summary of Product Characteristics Advisory Group
- Modelling and Simulation Working 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 inspections.
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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- Procedural advice for the Committee for Medicinal Products for Human Use on the need to convene a scientific advisory group or ad-hoc expert meeting (2011-07-27)
- Reflection paper on working parties: Committee for Medicinal Products for Human Use/European Medicines Agency group analysis and proposals (2010-10-25)