EMA: Update on recommendations for handling nitrosamines
On 22 February 2021, the European Medicines Agency (EMA) published a 14-page implementation plan dealing with the prevention of nitrosamine impurities. It is based on the results of the CHMP's scientific review of the subject.
The European Medicines Regulatory Network (EMRN) held a meeting on this and has now presented a harmonized implementation approach on the results:
In the process,the according Q&A was also revised
Questions 3, 4, 5, and 8 have been updated as the following templates have changed:
- Step 1 - No risk identified response template
- Step 1 - Risk identified response template
- Step 1 - Risk identified response template
- Step 2 - No nitrosamine detected response template
- Step 2 - Nitrosamine detected response template
- Step 2 - Nitrosamine detected response template
Source:
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