EMA Issues Guidance to Avoid Nitrosamine Impurities

 European Medicines Agency’s (EMA) issues guidance to avoid Nitrosamine in human medicines. EMA continue to monitor the presence of nitrosamine impurities in medicines, in co-operation with regulators from outside the European Union (EU), and to work with marketing authorisation holders to find rapid solutions to address any adverse findings. EMA carried out a review Article 5(3) from September 2019 to June 2020, the guidance to marketing authorisation holders, how to avoid the presence of nitrosamine impurities in human medicines. The CHMP has asked marketing  authorisation holders to review their medicines for the possible presence of nitrosamines and test all products at risk, as mentioned in theguidance and review their manufacturing processes to identify and, if necessary, mitigate the risk of presence of nitrosamine impurities in three steps. The European medicines regulatory network has agreed to extend the deadline to complete step 1  to 1^st October 2020.This follows reports of the challenges encountered in meeting the original deadline of 26 March 2020, and the impact of the severe restrictions in place to combat the COVID-19 pandemic. The European medicines regulatory encourages marketing authorisation holders to submit the outcome of step 1 before 1^st October 2020 if they complete the risk evaluation or identify a risk in their products. Marketing authorisation holders should inform the national competent authorities as soon as possible if tests confirm the presence of nitrosamine, irrespective of the amount detected, assess the immediate risk to patients to take appropriate action to avoid or minimise the exposure of patients to nitrosamines. The European medicines regulatory network plans to complete this exercise by 26 September 2022.

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