Marketing authorization holders (MAHs) have until next year to assess whether chemically synthesized active substances may be contaminated with nitrosamines, under a deadline extension granted by Swissmedic.
One year ago, Swissmedic gave MAHs until mid-May to assess the risk of nitrosamine contamination. The pandemic prompted Swissmedic to push back that deadline to the start of October. Swissmedic assessed compliance with the revised deadline last month, revealing that “a large majority of the companies had not managed to complete” the work on time, and pushed the deadline to 31 March 2021. MAHs of biological medicines have until 1 July 2021.
The delay had knock-on effects on the timelines for confirmatory testing and authorization changes that MAHs will need to undertake if they discover a risk of nitrosamine formation. The deadline for biological medicines is now 1 July 2023, although Swissmedic stuck with its 1 October 2022 deadline for chemical medicines...[Swissmedic]