messages in brief Created: 27.09.2019
Information for marketing authorisation holders: Request to evaluate the risk of the presence of nitrosamine impurities in human medicinal products containing chemically synthesised active pharmaceutical ingredients
After detection of nitrosamine impurities in sartans in 2018, within an Article 31 review of sartans at risk of containing nitrosamine impurities (i.e. sartans with a tetrazole ring) it was concluded that manufacturers must review and make necessary changes to their manufacturing processes to minimise nitrosamine impurities as much as possible. In addition, strict limits were set for nitrosamines in these products.
The findings of the review indicate that there is a potential for nitrosamines to be present in APIs for other medicines (i.e. non-sartans APIs), depending on the API and the finished product manufacturing processes.
Therefore, despite the low risk of nitrosamines being present, a scientific evaluation by the Committee for Medicinal Products for Human Use (CHMP) was initiated in September 2019 in accordance with Article 5(3) of Regulation (EC) No 726/2004.
All marketing authorisation holders are asked to review their manufacturing processes and take precautionary measures to mitigate the risk of nitrosamine formation or presence during the manufacture of all medicinal products containing chemically synthesized APIs.
Further information can be found
- on the homepage of the European Medicines Agency (EMA)
- and the Coordination Group (CMDh)
Information on nitrosamines for marketing authorisation holders
The CMDh and BASG will soon publish further information on the submission of the required assessments.