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Participants at the first meeting of the Working Group, Geneva 27-28 April 2017

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Drug-Induced Liver Injury (DILI)


The incidence of drug induced liver injury (DILI) is a growing challenge because of the ever-increasing number of drugs used in medical care. DILI is responsible for more than 10% of all cases of acute liver failure, posing a major clinical and regulatory challenge. In a recent and well-executed population-based study, the crude annual incidence of DILI was 19.1 cases per 100,000 persons (95% CI, 1.54-23.3).

The clinical pattern of DILI is diverse and can mimic almost any form of liver disease, ranging from asymptomatic elevation in aminotransferases to severe disease such as cirrhosis or acute hepatitis leading to acute liver failure, making it difficult for an easy and early diagnosis. It remains largely unpredictable and is not amenable to efficient preventive measures.

In many instances, the hepatotoxic potential of a medicine can only be recognized once a product is on the market, and DILI is one of the most frequent reasons for withdrawal of products from the market and modification of labelling. Being an important cause of mortality and liver transplantation, and a leading cause of attrition in drug development DILI remains a public health issue of great importance which needs additional international consensus guidance.

Working Group objectives

In 2017, CIOMS launched a Working Group composed of key stakeholders, including regulators, academia and industry partners, to address the present knowledge and practice gaps related to drug-induced liver injury (DILI). The group will formulate pragmatic, consensus-based recommendations to address the issues listed above.


  • 1st meeting held on  27-28 April 2017, Geneva, Switzerland (minutes)
  • 2nd meeting held on 14-15 November 2017, Málaga, Spain (minutes)
  • 3rd meeting  held on 8-9 May 2018, Reykjavík, Iceland (minutes)
  • 4th meeting held on 27– 28 November 2018, Aix-en-Provence, France


CIOMS Working Groups usually take 2-4 years to finalize their guidance and recommendations. Most groups hold two in-person meetings per year, with telework in between. The groups make use of collaborative efforts and capitalize on existing initiatives in order to provide output that is as comprehensive as possible, does not duplicate other efforts and has added value.


Upcoming Meetings

15 - 16 May 2019

Tallinn, Estonia

5th meeting of Drug-induced Liver Injury Working Group

01 - 02 May 2019

Geneva, Switzerland

3rd Meeting Working Group XI Patient Involvement in Developmnt/Safe Use Medicines

02 - 03 April 2019

Geneva, Switzerland

15th Meeting of the Implementation Working Group on MedDRA

27 - 28 February 2019

Geneva, Switzerland

4th meeting of Clinical Research in Resource-Limited Settings Working Group

Recent Meetings