About MedDRA

MedDRA - the Medical Dictionary for Regulatory Activities - is a pragmatic, clinically validated terminology that applies to all phases of drug development, excluding animal toxicology. It also applies to the health effects and malfunction of medical devices. It was developed by the International Conference on Harmonisation (ICH) and is owned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) acting as trustee for the ICH Steering Committee.

MedDRA is used to report adverse event data from clinical trials, and for post-marketing reports and pharmacovigilance.

Standardised MedDRA Queries (SMQs)

Standardised MedDRA Queries (SMQs) were developed to facilitate retrieval of MedDRA-coded data as a first step in investigating drug safety issues in pharmacovigilance and clinical development. They were developed in a cooperative effort between the ICH and the Council for the International Organization of Medical Sciences (CIOMS).

SMQs are groupings of terms from one or more MedDRA System Organ Classes (SOCs) that relate to a defined medical condition or area of interest. They are intended to aid in case identification.

MedDRA Translations

As part of their subscription, MedDRA users are able to access all available EU language translations of MedDRA which currently include Czech, Dutch, French, German, Italian, Portuguese, and Spanish. The MedDRA-Chinese translation is available as of MedDRA Version 12.1. A fee is required to access the Chinese and Japanese translations of MedDRA.