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About MedDRA

MedDRA is a rich and highly specific, standardised medical terminology developed in the 1990s. It is now updated twice per year in 27 languages.

MedDRA facilitates the sharing of regulatory information internationally for medical products used by humans, including pharmaceuticals, vaccines and drug-device combination products.

A powerful tool, MedDRA is used for registration, documentation and safety monitoring of medical products before and after a product has been authorised for use.

MedDRA governance

The MedDRA Steering Committee is responsible for the operational aspects of MedDRA and reports to the ICH Management Committee.

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ICH M1PtC Working Group​

The ICH M1 Points to Consider (PTC) Working Group develops and maintains two PTC documents on the use of MedDRA, updated annually with the March release: ​

  • MedDRA Term Selection – for data entry (coding), to promote accurate and consistent term selection​
  • MedDRA Data Retrieval and Presentation – data retrieval and analysis, including guidance on the use of Standardised MedDRA Queries (SMQs) as tools for assisting with safety signal detection 

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MedDRA

The dedicated MedDRA website contains information on tools, training, subscriptions and much more.

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Subscribe

Find subscription types, rates, forms and further information on accessing MedDRA.

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Find training

To support the correct use of MedDRA, training is available to users in different formats, both digital and face to face.

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PTC documents

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