The CIOMS report Introduction to MedDRA Labelling Grouping (MLG): A standardized approach to grouping adverse reactions in product safety labels (2024) has been released, offering valuable insights into standardizing adverse reaction grouping in medical product labels.

The Medical Dictionary for Regulatory Activities (MedDRA) is a terminology developed by the International Council for Harmonisation (ICH). While it serves as a precise coding system for adverse events in medicines data analysis, its high granularity can hinder the communication of adverse reactions in product labelling for healthcare practitioners. Consequently, sponsors and regulators have begun developing their approaches to cluster similar adverse reaction terms in medical product prescribing information. However, without agreed-upon conventions, there is uncertainty about which adverse reaction terms are appropriate to group together. To enhance safety communication to patients and healthcare providers, a harmonized international approach to creating and using groups of MedDRA terms, known as “MedDRA Labelling Groupings (MLGs),” is urgently needed in medical product prescribing information.

Given its significant contributions from 2002 to 2016 towards designing Standardised MedDRA Queries, CIOMS assembled an Expert Working Group involving multiple major stakeholders to produce a consensus document on principles and considerations for MLG development. The recommendations outlined in this report are intended to be voluntary and applied to product labels consistently with existing regulatory frameworks.1

Access the full report here.

References

  1. Introduction to MedDRA Labeling Grouping (MLG) • COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES. (2024, March 19). COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES. https://cioms.ch/publications/product/introduction-mlg-report/

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