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EU Produces Guide On 'Challenges' To NASH Drug Development

 
• By Ian Schofield

Regulatory experience with the development of new medicines for non-alcoholic steatohepatitis is limited, and because of the high unmet need, a conditional marketing authorization approach should be considered, the European Medicines Agency says.

Hand holding a luminated liver shape
Treating fatty liver conditions is the focus of a new EU reflection paper • Source: Shutterstock

The European Medicines Agency has published a “reflection paper” on the regulatory requirements for new medicines for non-alcoholic steatohepatitis (NASH) in view of what it calls the “major challenges” to drug development caused by the specific characteristics of the disease.

The paper, which was published on 4 April and comes into effect on 1 October, provides a high-level description of the requirements for drug development in this field. “Due...

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