The PTM response to nitrosamine presence
a risk-based approach for the nitrosamines evaluation for Marketing Authorization Holders
In June 2018, authorities in the EU became aware of the presence of a nitrosamine, N-nitrosodimethylamine (NDMA), in valsartan from one manufacturer of active pharmaceutical ingredients (APIs). Subsequently another nitrosamine, N-nitrosodiethylamine (NDEA), was detected and other sartans from more API manufacturers were later implicated. NDMA and NDEA are classified as probable human carcinogens and their presence in sartans was, at the time, unexpected.
EMA’s human medicines committee (CHMP) is requesting as a matter of precaution that marketing authorisation holders for human medicines containing chemically synthesised active substances review their medicines for the possible presence of nitrosamines and test all products at risk. The request is addressed at Marketing Authorization Holders (MAH) who within the next six months from the publication of the EMA (EMA / 189634/2019, published on 26 September 2019) must perform a risk assessment, with the possibility of prioritizing their products following risk-based approaches in accordance with ICH Q9 principles and tools.
Thanks to its experience in risk-based methodologies and approaches, PTM Consulting provides pharmaceutical companies with the support needed to achieve a risk-based classification of their products in accordance with EMA requests. This approach allows firstly to define priorities for products that will be subjected to a subsequent evaluation and / or tests, then the necessary mitigations for an effective control strategy will be planned.
This service is addressed both to Marketing Authorization Holders and active-ingredients producers: risk assessment in fact considers both the product and the potential cross-contamination along the production process chain in order to ensure product safety.