News about GMP/cGMP

02.10.2020

EMA reports extension of deadline for nitrosamine risk assessment

The EMA (European Medicines Agency) announces that the deadline for the completion of a risk assessment for all chemically defined human medicinal products that bear the risk of nitrosamine formation or (cross)contamination will be extended until 31 March 2021. For biological medicinal products, the final date for completion of a risk assessment will be 1 July 2020.

This announcement was made immediately prior to the original completion date, October 1, 2020, giving all companies concerned more time to review their manufacturing processes in order to carry out the required risk assessment (Step 1 conduct of risk evaluation).  A detailed description of all requirements and access to the Step 1, 2 and 3 templates can be found here.  

Please note that the corresponding Q&A document will be adapted by the EMA. The currently effective version of August 3, 2020 can be found here. We will keep you informed about further updates of the document.  

The German BfArM also published a notification regarding this update.  


Source:

EMA: Nitrosamine website



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