IMDRF Adverse Event Terminology Maintenance
IMDRF Adverse Event Terminology Working Group and the MHRA will host a webinar on Thursday 24th October 2024 to discuss the “Considerations for the Selection of IMDRF Adverse Event Terminology - A Guide for Industry Partners and Healthcare Providers”, a guidance document that is currently published for consultation here
The webinar is scheduled as a virtual event and will be hosted by the MHRA. For further details and to register, please refer to the IMDRF Event.
- The terms in the Annexes of the final version of the guideline document are maintained by the AE Working Group (AE WG) in accordance with the "Maintenance of IMDRF AE Terminologies" (IMDRF/AE WG/N44)FINAL:2020).
- The terminology is always open for Change Requests. The process is outlined in the figure below. The cutoff date for inclusion in the next release is 1 September. The Change Requests will then be reviewed by IMDRF, and the updated terminology and outcome of Change Requests will be published in March.
- Proposal of addition/modification/deletion of the terms must be submitted to AE WG by either National Competent Authorities or Stakeholder Organizations, using the Change Request form. No proposal from an individual will be accepted.
- Please use the most recent Change Request form below:
Appendices A & B: Change Request Form and Change Log - XLSX (16kb)
- Please send the completed form to: Terminology [at] mhra.gov.uk (Terminology[at]mhra[dot]gov[dot]uk)