Companion Diagnostic (CDx) Expert Group
The European Medicines Agency's (EMA) expert group on companion diagnostics advises the EMA's Committee for Medicinal Products for Human Use (CHMP) on procedures and relevant scientific issues.
EMA's CHMP convenes the Companion Diagnostic (CDx) expert group to provide input on procedures under evaluation by the CHMP.
The group's input can also refer to any other CHMP-relevant scientific issue on companion diagnostics.
For more information on EMA's working parties and other group, see:
Role
The CHMP set up this expert group to support and enhance EMA's regulatory and scientific input into the evaluation process, with a focus on personalised medicines.
The group role includes:
- giving scientific and regulatory advice to EMA committees about in vitro diagnostics (IVDs), especially during consultations and application procedures;
- updating guidelines and templates used during consultation procedures;
- creating guidance for the CHMP on how to write the product information, specifically for IVDs that help choose which patients should receive a medicine;
- tracking how biomarker-related information is reviewed during both initial approval and later updates to a medicine, to build knowledge.
The group may also act as a forum for sharing knowledge on clinical trials for medicines used in combination with IVDs.
Mandate
Information on the group's mandate is available in the document below:
Composition
The expert group consists of experts from the European regulatory network with expertise in the area of the in vitro diagnostics and companion diagnostics.
EMA selects the members from the European experts database according to their specific expertise. CHMP appoints these members.
The current group members are listed below in alphabetical order of surname.
The members' declarations of interests are available in the European expert list.