Medicines MA Holders submission of nitrosamine risk evaluation and assessment and confirmatory testing – Updated Guidance
The following updates have been added to this guidance: Further information is available at the link below. Source: MHRA
Pharmavibes
medicines-medical devices-regulatory affairs
Category nitrosamines
Read MoreMedicines MA Holders submission of nitrosamine risk evaluation and assessment and confirmatory testing – Updated Guidance
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…
FDA updates on possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products
The FDA has recently updated its information on possible mitigation strategies to reduce the risk of nitrosamine drug-substance related impurities in drug products (NDSRIs). Guidance for industry on nitrosamine was published in September 2020 and updated in February 2021. A…