Webinar Series on Impurities: Mutagenic Impurities with Focus on Nitrosamines - What do Regulatory Authorities Expect

In June 2018 EU authorities were notified that a Chinese API manufacturer has detected the presence of N-nitrosodimethylamine, NDMA, in batches of Valsartan. Meanwhile different Nitrosamines (NDMA, NDEA and others) were detected in several drug products containing Sartan derivatives as an API. NDMA is a genotoxic and carcinogenic agent in animals and is classified as a Class 2A carcinogen to humans. Therefore Marketing Authorisation Holders are requested to evaluate the risk of the presence of Nitrosamine impurities in human medicinal products containing chemically synthesised APIs and to take immediate steps to avoid nitrosamines in human medicines. As a consequence in case of any contamination with mutagenic impurities Marketing Authorisation Holders have to file a variation application. All regulatory activities with regard to such cases have to be completed within a 3 years period.