EMA to provide guidance on avoiding nitrosamines in human medicines

Sep 13, 2019 – EMA’s Executive Director has asked the human medicines committee (CHMP) to provide guidance for avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesised active substances. ‘We will continue to work with our partners to address the presence of nitrosamines and reassure patients about the quality of their medicines,’ says the Executive Director Professor Guido Rasi. ‘It is of paramount importance that … (leggi tutto)