EMA Provides Guidance on How to Avoid Nitrosamines in Human Medicines

September 20, 2019

A request has been made to the CHMP by the executive director of EMA to provide guidance on how to avoid the presence of nitrosamine impurities in human medicines.

A request has been made to the Committee for Medicinal Products for Human Use (CHMP) by the executive director of the European Medicines Agency (EMA) to provide guidance on how to avoid the presence of nitrosamine impurities in human medicines.

The request has come about as a result of the number of medicines affected by nitrosamine impurities in 2018, as well as the recent revelation that the impurity has also now been found in batches of pioglitazone and ranitidine. In response to the latest detection of nitrosamine, a European Union-wide review of the drug ranitidine has been initiated.

“We will continue to work with our partners to address the presence of nitrosamines and reassure patients about the quality of their medicines,” said EMA’s executive director, Guido Rasi, in a Sep. 13, 2019 press release. “It is of paramount importance that we learn from our experience with sartans and take a proactive approach for other classes of medicines.”

Within the release, it was confirmed that CHMP will now draw upon the work already performed by the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) to create guidance for marketing authorization holders (MAHs) on how to best avoid impurity contamination. This new guidance should be considered in conjunction with the manufacturing processes of products.

Further to the guidance for MAHs, CHMP will advise regulatory authorities on appropriate actions to take should a company find nitrosamine impurities in their medicines, based on a full evaluation of available scientific knowledge on the presence of the impurity in medicines. Additionally, CHMP will look at whether or not it is necessary to provide guidance for medicines that do not contain chemically synthesized APIs.

Source: EMA