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EMA issues opinion on nitrosamines in medicines

The agency’s opinion will require companies to take measures to reduce nitrosamine impurities in medicines and carry out and action the results of risk assessments.

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The European Medicines Agency (EMA)’s human medicines committee (CHMP) has issued an opinion requiring companies to take measures to limit the presence of nitrosamines in human medicines as much as possible and to ensure levels of these impurities do not exceed set limits.

The measures are intended to ensure nitrosamines are either not present or are present below levels identified to protect public health.

Companies will be required to have appropriate control strategies to prevent or limit the presence of these impurities and, where necessary, improve their manufacturing processes. They will also have to evaluate the risk of nitrosamines being present in medicines and carry out appropriate tests if a risk is identified.

Nitrosamines are classified as probable human carcinogens. The limits for nitrosamines in medicines have been set based on lifetime exposure, such that a patient should generally not be exposed to a lifetime risk of cancer exceeding 1 in 100,000 from nitrosamines in their medicines.

Further information for enterprises, including timelines, will soon be available under ‘updated documents’ on the EMA’s nitrosamines webpage. The EMA said that, until these are available companies should continue to follow current instructions.

Nitrosamine impurities were first highlighted by regulators in 2018 and regulatory actions, including recalling medicines and stopping the use of active substances from certain manufacturers, were taken to reduce human risk. A subsequent CHMP review of sartan blood pressure medicines in 2019 led to new requirements for their manufacture, while its review of ranitidine recommended in 2020 an EU-wide suspension of ranitidine medicines.

A more recent exercise to learn from the presence of nitrosamines in sartans has produced several recommendations to help prevent the presence of impurities in medicines. The recommendations complement the latest requirements from CHMP.

The EMA concluded that authorities in the EU will continue to take all necessary measures to protect patients and reassure them about the quality of their medicines.

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