Medical Dictionary for Regulatory Act...
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May
21
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Medical Dictionary for Regulatory Activities (MeDRA) by ICH
Regulatory Affairs
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The factsheet provides information on how organisations can access the Medical Dictionary for Regulatory Activities (MedDRA), as well as work by the ICH MedDRA Management Board to ensure that MedDRA is accessible to all those that need it. The factsheet contains information on how to obtain a MedDRA subscription, as well as how regulatory authorities may request a special licence.

The primary intent of the ICH in developing the Medical Dictionary for Regulatory Activities (MedDRA) was to improve communication among and between industry and regulators by facilitating electronic communication. This objective was supported by having the terminology available in multiple languages. The first version of MedDRA was released in 1999 in English and Japanese.

Accessing MedDRA Factsheet



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