MedDRA is a new international medical terminology designed to support the classification, retrieval, presentation, and communication of medical information throughout the medical product regulatory cycle. MedDRA was developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

The MedDRA Maintenance and Support Services Organization (MSSO) holds a contract with the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) to maintain and support the implementation of the terminology. For more information regarding the terminology, including how to subscribe or obtain training, see www.meddramsso.com, or contact the MSSO at telephone 877-258-8280 (toll-free), telephone 703-345-7799 (USA), fax 703-345-7791 (USA), or e-mail for subscriptions mssosubscribe@ngc.com.

In November 1997 the FDA replaced its Spontaneous Reporting System (SRS) and the Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART ) Terminology with the new Adverse Events Reporting System (AERS) and the MedDRA Terminology.

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