MedDRA

Medical Dictionary for Regulatory Activities

MedDRA is a rich and highly specific standardised medical terminology first developed by ICH in the late 1990s to facilitate sharing of regulatory information internationally for medical products used by humans.

A powerful tool, MedDRA is used for registration, documentation and safety monitoring of medical products before and after a product has been authorised for sale. Products covered by the scope of MedDRA include pharmaceuticals, vaccines and drug-device combination products.

The growing use of MedDRA worldwide by regulatory authorities, global pharmaceutical companies, clinical research organisations and health care professionals allows better global protection of patient health.

MedDRA governance

ICH has created a governance structure to protect the integrity of MedDRA. The ICH MedDRA Steering Committee has overall responsibility for the direction of MedDRA and oversees all the activities of the ICH MedDRA Maintenance and Support Services Organisation (MSSO), which maintains, develops and distributes MedDRA.

ICH has also established a Japanese Maintenance Organisation (JMO), which works in close collaboration with MSSO to support users in Japan.

MedDRA Steering Committee

The MedDRA Steering Committee met in Singapore at ICH 51 in November 2025

Multilingual

In addition to the original English and Japanese translation, MedDRA has been translated into and is maintained in 25 additional languages, with more being planned.

Each MedDRA term has an associated numeric code that remains the same, regardless of the language.

Affordable – and free for government regulators

MedDRA subscriptions are available at no charge to all pharmaceutical regulators worldwide.

Free training for users

Free training is offered to all MedDRA subscribers on a wide range of topics and in different formats including webinars and e-learning.

Free support tools

MedDRA is continuously enhanced to meet the evolving needs of its users worldwide.

  • MedDRA Term Selection – for data entry (coding)
  • MedDRA Data Retrieval and Presentation – for analysis and signal detection
  • What’s New documentation
  • Introductory Guide
  • SMQ Guide
MedDRA Points to Consider (PTC) & Other Documents

Digital tools include

  • MedDRA browsers
  • MVAT tool
  • WebCR tool

Direct support for users

Subscribers have access to direct support through the MedDRA Help Desk.

MedDRA User Group meetings are also organised in different regions of the world throughout the year.