EU Guidance Assists With Nitrosamine Evaluations
Guide Explains Steps Needed For Risk Evaluations And Confirmatory Testing
The EU guide covers medicines authorized at the national level and under the mutual recognition and decentralized procedures.
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Testing carried out by Australia's drug agency on batches of 34 ranitidine products marketed by 10 different sponsors has found high levels of NDMA contamination in the vast majority of cases. The agency is now considering tightening its oversight of all ranitidine drugs sold in Australia.
As companies evaluate scores of products for the possible presence of nitrosamine impurities, the EU regulator has listed potential sources of contamination identified to date to help sponsors develop a risk-based approach for their evaluations.
As companies undergo pharmacovigilance inspections from a growing multitude of regulatory authorities from around the globe, a senior pharmaceutical industry executive discusses how her company has been handling this complex and challenging task.