Need for the development of a reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)

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Concept paper

Reference numberEMA/CHMP/197320/2017
Published01/06/2017
Deadline for comments31/08/2017
Keywordsnon-alcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), clinical trial designs, endpoints, conditional licensing, unmet medical need, liver biopsy
DescriptionThe drafting of a reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) is intended in order to address and to avoid potential pitfalls in drug development.

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