Expert Working Group on MedDRA Labelling Groupings
On 8 August 2022, the Working Group published an article entitled “MedDRA Labeling Groupings to Improve Safety Communication in Product Labels” in the Journal Therapeutic Innovation & Regulatory Science.
Download it here.
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Working Group milestones
At the September 2018 MedDRA SMQ Working Group meeting, participants discussed the concept of MedDRA Labelling Groupings (MLGs) for use in reference safety information (minutes). A concept paper and a more concise one-pager were then submitted to the ICH MedDRA Management Committee for consideration and received their green light for further exploration.
The MLG concept was also presented at the 18th Annual meeting of the International Society of Pharmacovigilance (ISoP), held in Geneva on 11-14 November 2018. Click here for details of the session and the presentations.
The MedDRA Labelling Groupings idea was presented and received with great interest in San Diego at the DIA 2019 conference on 25-26 June 2019:
- The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions
- A Perspicacious CIOMS View of a Sometimes Tangled Mass of Adverse Reactions
- MedDRA Labeling Groupings (MLGs): A New CIOMS Initiative
- MedDRA Labeling Groupings (MLGs): Practical Examples Underscore Feasibility
MedDRA Labelling Groupings
Participants at the 2nd Working Group meeting on MedDRA Labelling Groupings
Although the established Medical Dictionary for Regulatory Activities (MedDRA) hierarchy provides groupings of related and meaningful medical concepts, these groupings can be of a broader scope, beyond the medical concepts intended for the label. Other types of groupings may also be needed to appropriately cluster individual MedDRA terms that convey the same clinical concept, thus supporting clearer communication. To this effect, several organizations have already independently created their own groups of medically related terms.
Working Group objectives
It is proposed that globally harmonized principles, points to consider, and pragmatic recommendations for development of MedDRA Labelling Groupings (MLGs) be developed by a Council for International Organizations of Medical Sciences (CIOMS) working group. The desired outcome is an international approach which would be available for voluntary consideration.
1st meeting held on 3-4 April 2019, Geneva, Switzerland (minutes)
2nd meeting held on 25-26 September 2019, Geneva, Switzerland (minutes)
3rd meeting held virtually on 25-26 August 2020 (minutes)
4th meeting held virtually on 4 March 2021 (minutes)
5th meeting held virtually on 8 December 2021 (minutes)
Working Group Members log in here for working documents.
06 - 07 June 2023
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30 May 2023
17th meeting of the Working Group XIII on Real-World Data & Evidence in Regulatory Decision-Making
12 April 2023