Working groups

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:

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.

Concept note one pager

Full concept note

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 to be held virtually on 4 March 2021

Working Group Members log in here for working documents.


Upcoming Meetings

04 March 2021

Virtual meeting

4th meeting of MedDRA Labelling Groupings Working Group

02 - 03 March 2021

Virtual meeting

4th meeting of the WG XII Benefit-Risk Balance for Medicinal Products

26 February 2021

Virtual meeting

6th Meeting Working Group XIII Real-World Data & Evidence in Regulatory Decision-Making

15 - 17 December 2020

Virtual meeting (15 and 17 December)

5th Meeting Working Group XIII Real-World Data & Evidence in Regulatory Decision-Making

Recent Meetings