Saturday, 21 December 2019

EMA releases guidance to companies on avoiding nitrosamines in drugs


The European Medicines Agency (EMA) has asked the human medicines committee (CHMP) to provide guidance on avoiding the presence of certain carcinogenic ingredients in drugs, after nitrosamines were found to be present in a prevalent form of blood pressure medication.

The regulatory body is drafting directions on nitrosamine impurities in medications containing chemically synthesised active substances.

The CHMP will produce guidance on reducing nitrosamine impurities to marketing authorisation holders.

“We will continue to work with our partners to address the presence of nitrosamines and reassure patients about the quality of their medicines,” says the Executive Director Professor Guido Rasi.


Nitrosamines are classified as probable human carcinogens, following animal studies.

Following the identification of the carcinogenic ingredient in sartans, the EMA is seeking a “proactive approach” for other classes of medicines. The ingredient has been detected in batches of pioglitazone and in batches of ranitidine.

See: https://www.ema.europa.eu/en/news/ema-advises-companies-steps-take-avoid-nitrosamines-human-medicines

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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