Consultation open

Considerations for the Selection of IMDRF Adverse Event Terminology

Start date
Closing date
Working group
Adverse Event Terminology

The objective of this document is to provide further guidance on the correct application and consistent use of the terminology. The document provides guidance for all stakeholders: 

• providing general coding principles on reporting incidents using IMDRF codes; 

and 

• providing examples to address common coding challenges.

IMDRF Adverse Event Terminology Working Group and the MHRA will host a virtual webinar on Thursday 24th October 2024 (3-4pm BST) to discuss this document. Refer to IMDRF Events for further information and how to register.

Consultation documents

Considerations for the Selection of IMDRF Adverse Event Terminology

Please use the comments template to provide comments on the Proposed Document and send comments to 

  • Nancy A. Pressly, Food and Drug Administration (FDA), United States of America, Nancy.Pressly [at] fda.hhs.gov (Nancy[dot]Pressly[at]fda[dot]hhs[dot]gov)
  • Andrea Hanson, Health Products Regulatory Authority (HPRA), Ireland, European Union, Andrea.Hanson [at] hpra.ie (Andrea[dot]Hanson[at]hpra[dot]ie)
  • Graham Nash (Maintenance Chair), Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom, graham.nash [at] mhra.gov.uk (graham[dot]nash[at]mhra[dot]gov[dot]uk)

with the subject line 'Public Consultation on “Considerations for the Selection of IMDRF Adverse Event Terminology'

Considerations for the Selection of IMDRF Adverse Event Terminology - Consultation Template

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)