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  • EMA Issues Guidance to Avoid Nitrosamine Impurities

    Guidance to avoid Nitrosamine Impurities:

    European Medicines Agency (EMA) issues guidance to avoid Nitrosamine in human medicines. EMA continues to monitor the presence of nitrosamine impurities in medicines, in cooperation with regulators from outside the European Union (EU), and to work with marketing authorization holders to find rapid solutions to address any adverse findings. EMA carried out a review of Article 5(3) from September 2019 to June 2020, the guidance to marketing authorization holders, on how to avoid the presence of nitrosamine impurities in human medicines. The CHMP has asked marketing authorization holders to review their medicines for the possible presence of nitrosamines and test all products at risk, as mentioned in the guidance, and review their manufacturing processes to identify and, if necessary, mitigate the risk of the presence of nitrosamine impurities in three steps. The European medicines regulatory network has agreed to extend the deadline to complete step 1  to 1st 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 authorization holders to submit the outcome of step 1 before 1st October 2020 if they complete the risk evaluation or identify a risk in their products. Marketing authorization holders should inform the national competent authorities as soon as possible if tests confirm the presence of nitrosamine, irrespective of the amount detected, and assess the immediate risk to patients to take appropriate action to avoid or minimize the exposure of patients to nitrosamines. The European medicines regulatory network plans to complete this exercise by 26 September 2022.

    At all steps, timelines should be shortened and marketing authorization holders should immediately inform authorities if findings indicate an immediate risk to public health.

    Step 1: Conduct a risk evaluation to identify active substances and finished products at risk of N-nitrosamine formation or (cross-) contamination and report by 1 October 2020. If a risk for an active substance is identified, marketing authorization holders submit the step 1 response template and proceed with step 2 confirmatory testing of the finished product. If no risk is identified, marketing authorization holders should conduct a risk evaluation of the finished product and submit the outcome of step 1 only when they reach a final conclusion on the active substance and finished product.

    Step 2: Confirmatory testing on the products to be at risk of N-nitrosamine formation or (cross-) contamination.

    Step 3: Apply any necessary changes to the manufacturing process resulting from this review using the established regulatory procedures.


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