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EMA Advice on Nitrosamines

As of September 26, 2019, the EMA’s human medicines committee (CHMP) is requesting as a matter of precaution that marketing authorization holders (MAH) for human medicines containing chemically synthesized active substances review their medicines for the possible presence of nitrosamines, and test all products at risk as soon as possible. Originally the deadline for step 1 (risk assessment) was scheduled for March 26 2020, but this was extended to October 1 2020, following reports that MAH’s would need more time given the impact of the severe restrictions in place to combat the COVID-19 pandemic.

ProPharma Group, with our global scientific and drug manufacturing experts, are uniquely positioned to help companies that use chemically synthesized APIs, to overcome this significant challenge to comply with EMA advice and ultimately ensure patient safety. Read our blog on the next three steps that have to be taken.

The key for success in this regulated, yet complex environment is employing a results-driven program from day one, making use of a chemistry-based strategy, which will enable companies to streamline the required effort for both Risk Assessment, as well as Analytical Method development and validation.

This results in two immediate scope items:

  • Perform Risk Assessment for products by 1 October 2020 at the latest
  • Confirm control of nitrosamine content, by means of analytical testing

The risk assessment must be completed by October 1 2020. The ultimate goal of this investigation is the elimination of nitrosamine impurities from pharmaceutical products. EMA plans to complete this exercise by September 26 2022.

ProPharma Group has the global Scientific, Quality, Formulation and Regulatory expertise essential to fulfilling this requirement from EMA and ensure control of nitrosamine presence in medicinal products for human use.