Updated Swissmedic requirements for dealing with potential nitrosamine impurities in medicinal products, plus identification and reporting deadlines for NDSRIs in certain categories
In summer 2018, drug regulatory authorities first became aware of nitrosamine impurities in a number of medicinal products, including antihypertensives in the sartans class. Trace amounts of nitrosamine impurities were also subsequently detected in other medicinal products.Swissmedic evaluates and oversees…