EMA: Nitrosamine limits for active ingredients now apply to the finished products
In a statement dated 13 November 2020, EMA announces that its CHMP (Committee for Medicinal Products for Human Use) has aligned recommendations for limiting nitrosamine impurities in sartan medicines with recent recommendations it issued for other classes of medicines.
The main change concerns the limits for nitrosamines, which previously applied to the active ingredients but will now apply instead to the finished products (e.g. tablets). These limits, based on internationally agreed standards (ICH M7(R1)), should ensure that the excess risk of cancer from nitrosamines in any sartan medicines is below 1 in 100,000 for a person taking the medicine for lifelong treatment.
In line with previous recommendations, companies are called upon to introduce appropriate control strategies to prevent or limit the presence of nitrosamine contamination as far as possible. If necessary, manufacturing processes have to be adapted and optimised. Companies should also assess the risk of the presence of nitrosamines in their drugs and carry out appropriate tests.
Source:
EMA: Alignment of recommendations for sartans with those for other medicines
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