EMA extends nitrosamine risk assessments to investigational drugs

Our experts were recently informed by EMA that the nitrosamine risk assessment is now also required for investigational medicinal products (IMPs) and is expected to be included in the IMPD.

In addition, EMA has now extended the deadline to complete the nitrosamines risk evaluation for commercial drugs to October 1st, 2020 due to reports on the challenges encountered by several companies to meet the original deadline and restrictions in place to combat the COVID-19 pandemic. An updated Q&A has been published on March 27th.

We have set up a dedicated team to perform these risk assessments and have completed more than 100 to date. Please contact us for more information on our nitrosamine risk assessment support.