Expert Working Group on MedDRA Labelling Groupings
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.
Most recently, 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
First 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.
The next meeting will be held in Geneva, Switzerland on 25-26 September 2019.
18 December 2019
CIOMS 86th Executive Committee Meeting and XXIII General Assembly
16 - 17 October 2019
4th Meeting Working Group XI Patient Involvement in Developmnt/Safe Use Medicines
08 - 09 October 2019
5th meeting of Clinical Research in Resource-Limited Settings Working Group
25 - 26 September 2019