Medical Writing Regulatory Writing Basics Adverse event reporting: A brief overview of MedDRA

Volume 23, Issue 2 - Regulatory Writing Basics

Adverse event reporting: A brief overview of MedDRA

Abstract

Since its inception 20 years ago, the Medical Dictionary for Regulatory Activities (MedDRA) has become the lingua franca of safety reporting in a regulatory context. The standardised reporting across different regulatory regions and languages is a major strength of MedDRA. The detail offered by the large number of terms may, in principle, be considered an advantage too, but increased granularity is not without its problems. Awareness of the potential issues with MedDRA should help medical writers provide clear, transparent safety reporting.

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References

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