Europe – Reflection paper on regulatory requirements for the 5 development of medicinal products for chronic non6 infectious liver diseases (PBC, PSC, NASH).

Chronic, non-infectious liver diseases are a medical field of high unmet medical needs. At the same time, the specifics of the diseases create major challenges for the development of new medicinal products. This reflection paper restricts the current regulatory approach to 3 different disease entities primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), and non-alcoholic steatohepatitis (NASH) for which recent efforts are undertaken to bring new medicinal products to the market. It is anticipated that many of the problems raised and potential solutions described in this reflection paper, may be transferrable to other chronic liver diseases.