Medical Dictionary for Regulatory Activities

Mousley Consulting is pleased to see that after many years of numerous “do-it-yourself” medical terminology coding dictionaries in use by Biopharmas, the FDA has committed to a standard dictionary, and that this dictionary has become the standard for adverse event reporting in the USA. This fairly recent commitment is to the Medical Dictionary for Regulatory Activities, commonly known as MedDRA.

For many years Biopharmas performed medical terminology coding using their own private dictionaries developed totally “in-house” or modified in some way from one or more dictionary sources such as Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART), World Health Organization - Adverse Reactions Terminology (WHO-ART), International Classification of Diseases (ICD9), and World Health Organization – Drug (WHO-DRUG) resulting in a hodgepodge of dictionaries and coding schemas.

In order to bring consistency and uniformity to the coded data being submitted to it, the FDA has recently committed to a standard coding dictionary, namely MedDRA. In addition to the FDA’s selection of MedDRA, the International Conference on Harmonization (ICH) backs MedDRA and the European Union and Japanese regulatory bodies mandate the use of MedDRA for safety reporting.

In this article, we explore the fundamentals of MedDRA, hoping to provide a primer in medical terminology coding for the uninitiated, non-dictionary group, persons otherwise involved in clinical trials. We begin by discussing the need for coding, and then delve into MedDRA, its structure, its use, and why we are pleased to see it after all these years.

Readers are encouraged to share feedback and suggestions regarding this article, and welcome suggestions of topics.

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