Swissmedic: Harmonization of requirements on nitrosamines with EU
On 16 April 2021, Swissmedic announced that it is seeking harmonization with EU regulations regarding the handling of nitrosamine impurities.
Swissmedic refers to the corresponding documents of the EMA:
- European Medicines Regulatory Network approach for the implementation of the CHMP Opinion pursuant to Article 5(3) of Regulation (EC) No 726/2004 for nitrosamine impurities in human medicines
- Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
- EMA/369136/2020: Committee for Medicinal Products for Human Use (CHMP) Assessment report Procedure under Article 5(3) of Regulation EC (No) 726/2004 Nitrosamine impurities in human medicinal products (25 June 2020)
However, the following exceptions exist:
- For medicinal products with biological and biotechnological active substances, Swissmedic only expects further investigations if risk factors exist in excipients or manufacturing conditions.
- Step 1: In Switzerland, no documents have to be submitted to Swissmedic once Step 1 "Risk Evaluation" has been completed with no risks identified. In the EU, documents must be submitted after this step. This exception also applies to medicinal products that have already been authorized.
- In the case of metformin preparations, the previous regulations remain in place for the time being due to the unresolved reasons for NDMA contamination.
So far, Swissmedic required the use of a method with a Limit of Quantification (LOQ) of 30 ppb. This requirement does not apply any longer.
Swissmedic: Potential nitrosamine contamination
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