The Medical Dictionary for Regulatory Activities (MedDRA) is a terminology developed by the International Council for Harmonisation (ICH). While it is useful for precise coding of adverse events of medicines for data analysis, its high granularity can obscure the safety communication in product labeling for healthcare practitioners.
Many sponsors and regulators have therefore begun to develop their own approaches to clustering similar adverse reaction terms in medical product prescribing information on a product-by-product basis. However, there are no agreed-upon conventions that describe which adverse reaction terms may be appropriate to group together.
The CIOMS Expert Working Group for MedDRA Labeling Groupings (MLG) proposed the consensus recommendations on principles and points to consider in the development of MLGs in the 2024 report:
Introduction to MedDRA Labeling Grouping (MLG): A standardized approach to grouping adverse reactions in product safety labels.
https://doi.org/10.56759/hmku5307
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