27 October 2020
After N-nitrosodimethylamine (NDMA) and other Nitrosamines have been found in numerous medicines, the European Medicines Agency (EMA) has asked marketing authorisation holders (MAHs) to take precautionary measures to mitigate the risk of nitrosamine formation or presence during the manufacture of all medicines containing chemically synthesised active substances as described in the document Information on Nitrosamines for marketing authorisation holders which was published on 26 September 2019. The MAHs were obliged to submit their risk assessments for drug products to the authorities within 6 months. Within this period, it turned out that it was a big challenge to meet the deadline of 26 March 2020 for providing these risk evaluations due to difficulties in getting all relevant information from the suppliers of APIs, raw materials and other indirect materials. A major obstacle is now the shutdown of many sites due to the COVID-19 pandemia.
The European medicines regulatory network has now agreed to extend the deadline for the submission of the risk evaluations to 1 October 2020. As before, MAHs are obliged to inform the national competent authorities as soon as possible if tests confirm the presence of nitrosamine, irrespective of the amount detected.
Moreover the EDQM has announced on its webpage the extension of the deadline for completion of risk evaluation for CEP-Holders until 31 July 2020. Confirmatory testing and, if required, changes to a CEP have to be completed by 26 September 2022.
With the earlier deadline (31 July 2020) EDQM wants to ensure that information on drug substances subject of CEPs is available in due time. This supports MAHs in meeting the extended deadline for their medicinal products.