EMA and FDA Requirements for Control of Nitrosamine Impurities

As of September 2020, both EMA and FDA are requiring that all human medicines, irrespective of the marketing status, are assessed for the possible presence of nitrosamines. FDA requires the completion of a risk assessment for chemical products by February 28, 2021 and EMA by 31 March 2021, with EMA providing an additional three months for biological products.

ProPharma Group’s global scientific and drug manufacturing expertise is uniquely positioned to help companies overcome the significant challenge of complying with EMA and FDA requirements and ultimately, ensuring patient safety. Read our blog on the next three steps that must be taken .

The key to success is a timely communication with providers of external materials (excipients, packages, equipment etc.) or facilities (CMOs or CROs) and utilizing the knowledge of the multidisciplinary team in the performance of the tailored Risk Assessment, as well as Analytical Method development and validation.

If you need support to meet nitrosamine regulatory requirements, please contact ProPharma Group. ProPharma Group has the expertise essential to satisfy these demands. Through close collaboration with you, we will ensure control of nitrosamine impurities in medicinal products for human use.

The Immediate Scope Items

  • Both EMA and FDA require completion of the risk assessment for chemical products in the first quarter of 2020
  • Both EMA and FDA recommend that the effort to develop confirmatory testing should immediately be undertaken for products designated as high risk, by the manufacturer of newly filed, approved or marketed products.

Future Scope

EMA and FDA currently require the control of nitrosamine impurities at acceptably low levels in chemical products, by September 2022 and September 2023 , respectively, with EMA providing an additional nine (9) months for biological products (by July 1, 2023). To achieve this, manufacturers will be required to perform confirmatory testing of their drug products at risk and submit to the applicable regulatory authorities, revisions to drug applications that may be required to control nitrosamine impurities.

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