medicines-medical devices-regulatory affairs
This guidance has been updated to include sections on the following: Lifecycle management MAHs are reminded of their responsibilities to ensure the quality, safety and efficacy of their medicines and are expected to continue to review and re-visit the outcome…
Swissmedic enshrines the requirement to submit risk assessments regarding nitrosamines in active substances and/or finished medicinal products in the relevant specification documents. Update 18 June 2025 Source: Swissmedic
The following updates have been added to this guidance: Further information is available at the link below. Source: MHRA
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…
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…