In 2018, nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were detected in some medicinal products for the treatment of high blood pressure known as “sartans”. This led to the recall of some products and a review of regulatory norms establishing new strict requirements for the manufacture of these medicinal products. Subsequently, nitrosamine impurities were detected in batches of ranitidine, a medicinal product used to treat heartburn and stomach ulcers.
Nitrosamines are chemical compounds classified as probable human carcinogens based on animal studies. However, there is a very low risk that nitrosamine impurities at the levels found could cause cancer in humans.
EMA asked registration certificate holders to take precautionary measures to reduce the risk of nitrosamine formation or presence during the manufacture of all medicinal products containing chemically synthesized active substances.
EMA and national competent authorities continue to monitor the presence of nitrosamine impurities in medicinal products in cooperation with regulatory authorities outside the EU. EMA will also work with registration certificate holders to find quick solutions to eliminate any adverse results.
Link to the guidance on preventing the presence of nitrosamine impurities in medicinal products for registration certificate holdershttps://www.ema.europa.eu/en/documents/referral/nitrosamines-emea-h-a53-1490-information-nitrosamines-marketing-authorisation-holders_en.pdf
Link to the EMA press releasehttps://www.ema.europa.eu/en/human-regulatory/post-authorisation/referral-procedures/nitrosamine-impurities-overview
