EMA raadpleging: Reflectiedocument over wettelijke vereisten voor de ontwikkeling van geneesmiddelen voor chronische niet-infectieuze leverziekten (PBC, PSC, NASH)
The European Medicines Agency has released for public consultation a reflection paper on regulatory requirements for the development of medicinal products for chronic non-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.
The reflection paper is available by clicking here.
Comments should be provided using this template and sent to GastroenterologyDG@ema.europa.eu by 31 August 2019.
Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).