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.

GMP Compliance Adviser

News about GMP/cGMP

Nitrosamine risk evaluation: Switzerland follows EU deadline extension