EMA to provide guidance on avoiding nitrosamines in medicines
Posted: 17 September 2019 | Victoria Rees (European Pharmaceutical Review) | No comments yet
The EMA has announced it is drafting guidance on how to avoid the presence of nitrosamines, a probable carcinogenic ingredient, 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.
The CHMP will produce guidance on reducing nitrosamine impurities to marketing authorisation holders, to consider alongside their manufacturing processes.
The committee will also consider whether to provide guidance for medicines other than those containing chemically synthesised active substances.
Related topics
Drug Manufacturing, Drug Safety, Formulation, Impurities, Manufacturing, QA/QC
