EMA Lays Out Three Steps for Nitrosamine Testing
The European Medicines Agency (EMA) has issued templates for marketing authorization holders to use when filing results of product testing for N-nitrosodimethylamine (NDMA) contamination.
Drugmakers should first conduct a risk evaluation to identify any drug products that may be contaminated with NDMA. The results of the initial test should be reported using the EMA’s template by no later than April 26, 2020.
Further confirmatory testing should be conducted on products that are at risk of being contaminated with the potential carcinogen and the EMA should be alerted as soon as possible if the contaminant is discovered using the appropriate template.