The MedDRA Expert Panel was established to provide feedback to the MSSO on difficult change requests and other problematic maintenance issues encountered by the MSSO. The recommendations developed by the Panel are presented to the MedDRA Management Board by the MSSO. The Expert Panel includes regulatory and industry panelists representing the three ICH regions (i.e., Europe, Japan, and USA).

There are several scenarios for which the Expert Panel may be asked to provide their opinion:

  • Existing concepts are controversial in their placement in MedDRA, the placement has been questioned by more than one user at different times, or a user has questioned a change request outcome
  • An existing term has been moved more than two times in a single release
  • The MSSO Medical Team cannot reach consensus on accepting or rejecting the requested change
  • The requested concept is out of the realm of expertise of the members of the Medical Team
  • The reference material available for the requested concept is either very limited or not available in English. In such situations, the user would first be contacted for more information. If the explanation/references are not satisfactory, the external Expert Panel may be consulted
  • In the course of implementing new concepts in MedDRA, the MSSO may wish to consult with the Expert Panel to understand the impact and value of the changes being developed.