A number of recalls have occurred in the last two years following the finding of nitrosamine impurities in medicinal products, firstly the ‘sartans’ and then other products, notably ranitidine. This has led to enhanced regulatory agency and pharmaceutical industry action to assess and manage the risks. In Europe, a key element of this was the issue in Sep-2019 of EMA’s ‘Information on nitrosamines for marketing authorisation holders’ which, in addition to providing useful information on the potential sources of nitrosamine impurities, contains a request from the CHMP for all marketing authorisation holders (MAH) of human medicines containing chemically synthesised active substances to review their medicines for the possible presence of nitrosamines and to test all products at risk. A three-step process was outlined: Risk Evaluation – Confirmatory Testing – Changes to Marketing Authorisation.
The original requirement was for the first step of Risk Evaluation to be completed by 26-Mar-2020. It has now been announced that, following reports of the challenges encountered in meeting the original deadline which have been compounded by the impact of the severe restrictions in place to combat the Covid-19 pandemic, this date has been extended to 01-Oct-2020.
MAH should still inform national competent authorities as soon as possible if tests confirm the presence of nitrosamine, irrespective of the amount detected. They should also assess the immediate risk to patients and take appropriate action to avoid or minimise the exposure of patients to nitrosamines.