IMDRF Adverse Event Terminology Maintenance

  • 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.
1. Stakeholder organization submits change request form (cutoff date: 1 September). 2. IMDRF AE TM WG (adverse event terminology maintenance group) - Considers change and makes recommendation to MC using change log. 3. IMDRF Management Committee (MC) makes positive or negative decision and submits change log to IMDRF AETMG. 4. IMDRF website - updated Terminology and Change Log 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)

Member sites

Regional harmonization initiatives

APEC LSIF Regulatory Harmonization Steering Committee

Global Harmonization Working Party (GHWP)

Pan American Health Organization (PAHO)

African Medical Devices Forum (AMDF)

Official observers

Argentina, National Administration of Drugs, Food and Medical Devices

The World Health Organization (WHO)

Saudi Arabia, Saudi Food and Drug Authority

Switzerland, Swissmedic

Affiliate members

Botswana - Botswana Medicines Regulatory Authority (BoMRA)

Chile - Public Health Institute of Chile (ISP)

Chinese Taipei Taiwan Food and Drug Administration (TFDA)

Costa Rica - Ministry of Health

Cuba - Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED)

Dominican Republic - General Directorate of Medicines, Food and Health Products (DIGEMAPS)

Egypt - Egyptian Drug Authority  (EDA)

El Salvador - Sanitary Regulation Superintendency (SRS)

Ethiopia - Ethiopian Food and Drug Authority (EFDA)

India - Central Drugs Standard Control Organization (CDSCO)

Israel - The Medical Technology, Health Information, Innovation and Research Directorate (MTIIR)

Affiliates

 

Jordan - Jordan Food and Drug Administration (JFDA)

Kenya - Pharmacy and Poisons Board (PPB)

Mexico - Federal Commission for Protection from Sanitary Risks (COFEPRIS)

Montenegro - Institute for Medicine and Medical Devices of Montenegro (CINMED)

Nigeria - National Agency for Food and Drug Administration Control (NAFDAC)

Oman - Drug Safety Center, Medical Device Control Department (DSC)

Paraguay - National Health Surveillance (DINAVISA)

Peru - General Directorate of Medicines, Supplies and Drugs (DIGEMID)

South Africa - South African Health Products Regulatory Authority (SAHPRA)

Tanzania - Tanzania Medicines and Medical Devices Authority (TMDA)

Zimbabwe - Medicines Control Authority (MCAZ)