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Version 5.0 of the Medical Dictionary for Regulatory Activities (MedDRA) Terminology — the new global standard medical terminology — was released in March.
The International Conference on Harmonisation (ICH) developed MedDRA as a pragmatic, clinically validated medical terminology. The emphasis is on ease-of-use data entry, retrieval, analysis, and display, with a balance between sensitivity and specificity, within the regulatory environment. MedDRA is applicable to all phases of drug development and applicable to the health effects of devices.
MedDRA also is designed to supersede or replace all other terminologies used within the medical product development process. The U.S. Food and Drug Administration already has implemented MedDRA within its Adverse Event Reporting System.
Proponents of MedDRA say that by standardizing medical terminology, it will help speed the exchange of clinical information, facilitate research and safety monitoring, and make the regulatory approval process more efficient and responsive. MedDRA may not be as user-friendly in the other direction, however, says Jack Fincham, PhD, dean and professor of pharmacy practice at the University of Kansas in Lawrence.
The main reason for this is MedDRA’s proprietary nature. Realizing that MedDRA would have to be continually maintained and updated, ICH created a Maintenance and Support Services Organization (MSSO) and established as its steering committee trustee the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) in Switzerland. The MSSO reports to IFPMA, and is the only officially authorized provider of MedDRA subscriptions and core services. Health care organizations with tight budgets may not be able to afford the subscriptions, Fincham says.
Along with the updated version of MedDRA, translations of MedDRA to French, German, Portuguese, and Spanish are now available or expected soon.