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MedDRA
The Medical Dictionary for Regulatory Activities (MedDRA) Terminology has been developed under the auspices of ICH.
This new international medical terminology is particularly important in the electronic transmission of adverse event reporting, both in the pre- and post- marketing areas, as well as the coding of clinical trial data.
The Terminology, however, requires to be constantly updated and maintained and it was agreed that a Maintenance and Support Service Organisation (MSSO) would be needed to carry out this task and to distribute the terminology, on license, to users in industry and regulatory agencies.
In November 1998, IFPMA which was established as the Trustee of the ICH Steering Committee for the purpose of holding the intellectual property rights (ownership) of the terminology, selected Northrop Grumman Mission Systems (formerly TRW Inc.) as the MSSO. Their activities are overseen by a Management Board (MB), composed of the 6 ICH parties, the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, the Health Canada, The World Health Organization and chaired by the IFPMA.
For further information on subscribing to MedDRA, contact Patrick Revelle at MedDRA MSSO, Northrop Grumman. E-mail: patrick.revelle@ngc.com
e-mail your question to the MedDRA
MB Members
Click on the MedDRA MSSO logo to enter their website