EMA has just informed us that nitrosamine risk assessments should now also be conducted for investigational drugs. In September 2019, EMA had already requested all marketing authorization holders to investigate their manufacturing processes for the risk of nitrosamine presence (press release and Q&A document).
Since EMA now extends this request to investigational medicinal products (IMPs), nitrosamine risk assessments should be available for IMPs in both ongoing and new clinical trials and are to be included in the IMPD.
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.