News about GMP/cGMP

13.11.2020

Nitrosamine risk evaluation: Switzerland follows EU deadline extension

On 9 November 2020, Swissmedic announced to further extend the deadline for the completion of a risk evaluation for medicinal products for human use with a risk of nitrosamine formation or (cross)contamination to 31 March 2021. For biological medicinal products, the final date for the completion of an evaluation is 1 July 2020. Switzerland is thus following the EU, which announced an extension of the deadline in early October.
 

Due to the COVID-19 crisis a majority of affected companies did not manage to complete the required risk evaluation (step 1 risk evaluation) as of 1 October 2020, the specified deadline. Those companies will now have more time to review their manufacturing processes and carry out the required risk evaluation. The deadlines for steps 2 and 3 (confirmatory tests and changes to the marketing authorization) currently remain unchanged: October 1, 2022 for synthetics and July 1, 2023 for biologicals.

In difference to the EU, Switzerland does not require

  • a submission of any documentation once the risk evaluation has been completed. However, the evaluation must be available in the course of inspections.
  • any general risk assessments for biologicals, but investigations will be called for when there are identifiable risk factors.

Source:

Swissmedic: News and Updates

EMA: Nitrosamine impurities



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