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 communication of adverse reactions 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. To improve safety communication to patients and healthcare providers, there is an urgent need for a harmonized international approach to the creation and use of groups of MedDRA terms, or “MedDRA Labeling Groupings (MLGs)”, in medical product prescribing information.

The use of the consensus recommendations proposed in this report would be voluntary and applied to product labels in a manner that is consistent with existing regulatory frameworks.

https://doi.org/10.56759/hmku5307