;   Medical Translation Insight: Primer: MedDRA, the Medical Dictionary for Regulatory Activities - ForeignExchange Translations

Primer: MedDRA, the Medical Dictionary for Regulatory Activities Medical translation professionals sometimes are confused when clients ask about a "medical dictionary" or "MedDRA". Is this a glossary? Translation memory? Is it already translated?

The Medical Dictionary for Regulatory Activities (MedDRA) was first initiated in 1993, then developed by the M1 expert working group of International Conference on Harmonisation. It was released worldwide in 1999 and today is managed by MSSO.

MedDRA is a pragmatic, clinically validated terminology used by regulatory authorities and the medical device / biopharmaceutical industry throughout the entire product life cycle, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation.

So, why is MedDRA important?

For many years drug and device firms performed medical terminology coding using their own private "in-house" dictionaries, resulting in a hodgepodge of dictionaries and coding schemas.

In order to bring consistency and uniformity to the coded data being submitted to it, regulatory agencies have committed to a standard coding dictionary, namely MedDRA. Today, MedDRA is the adverse event classification dictionary endorsed by ICH and is used in the U.S., European Union, and Japan. Its use is currently mandated in Europe and Japan for safety reporting.

MedDRA is available in Chinese, Czech, Dutch, French, German, Hungarian, Italian, Japanese, Portuguese, and Spanish. The subscription is required to access these languages (as well as English).

Our friends at Mousley Consulting have put together a terrific overview of the fundamentals of MedDRA [PDF link]. Take a look and get ready to answer questions about "international regulatory dictionary"!


ForeignExchange Translations provides specialized medical translations for regulatory, marketing, and clinical groups at pharma and device companies. Contact us to find out more.
 

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