The European Medicines Agency (EMA) announced that the deadline for the submission of risk assessments for all human medicines presenting a risk for the presence of nitrosamine impurities or (cross)contaminations will be extended to 1 October 2020. The announcement was made just one day ahead of the original deadline scheduled for 26 March 2020. This will give all companies affected more time to review their manufacturing processes and carry out the required risk assessments.
The reason given for this step is the challenges and impact of the restrictions in place to combat the COVID 19 pandemic.
The risk evaluation process now required as of October 1, 2020, corresponds to Step 1 (Step 1 conduct of risk evaluation) of the three-step process specified by the EMA. The results are reported back to the agency by the marketing authorisation holders using one of the two corresponding templates:
- the "No risk identified response template", confirming that no risk has been identified or
- the "Risk identified response template", confirming that a risk has been identified. In this case, a confirmation/nonconfirmation of a nitrosamine contamination must be sent directly to the EMA under Step 2 (Step 2 Perform further confirmatory testing).
A detailed description of all requirements and access to the templates of steps 1, 2 and 3 can be found here.
In the course of this process, the EMA has updated the 11-page Q&A document for MAHs. The following Q&As have been revised:
- Question 4 deals with the development of analytical methods for the determination of nitrosamines and is mentioned as a supplement for Step 2.
- Question 5 is mentioned as a further source of information for Step 1. It explains in detail how the results of the risk assessments can be submitted.
- Question 6 deals with interim limits. With the substantial number of APIs and finished products involved, final limits of nitrosamines for non-sartan products are still under consideration.
- Question 13 takes up the approach for new and ongoing applications for authorisation.
Click here to view the Q&A document.
EMA: Human Regulatory/Nitrosamine impurities