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 far as possible and to ensure levels of these impurities do not exceed set limits.
The measures will ensure that 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.
Companies will also have to evaluate the risk of nitrosamines being present in medicines and carry out appropriate tests if a risk is identified.
Press release 09/07/2020