There is an unmet medical need of pharmaceutical treatment options in the indications Primary Sclerosing Cholangitis (PSC) and Non-alcoholic steatohepatitis (NASH) and also the repertoire of effective and safe drugs for the treatment for Primary Biliary Cholangitis (PBC; previously termed “Primary Biliary Cirrhosis”) remains limited.

Whereas the number of development programs and potential future drug candidates has increased during recent years the current regulatory experience reveals the need for further guidance.

Therefore the 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.

Posted on the EMA website on 1 June 2017