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 by March 26, 2020, which is six months from this date, and test all products at risk as soon as possible.

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.

The key for success in this regulated1, 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 in a six-month timetable
  • Confirm control of nitrosamines content, by means of analytical testing

The risk assessment must be completed by March 26, 2020, which is the end of the six-month window that began with the release of the EMA advice on nitrosamines.

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

 


1https://www.ema.europa.eu/en/documents/referral/nitrosamines-emea-h-a53-1490-information-nitrosamines-marketing-authorisation-holders_en.pdf
https://www.ema.europa.eu/en/documents/referral/nitrosamines-emea-h-a53-1490-questions-answers-information-nitrosamines-marketing-authorisation_en.pdf