There are lots of important topics discussed in the second meeting of the NIOG with industry stakeholders such as the current status of call for review, the policy on confirmatory testing, approach in case of presence of multiple nitrosamines, approach for dealing with dis-harmonization of limits and facilitate reporting of the call for review.
And more industry scientific data is needed in order to progress on critical topics such as the approach
for mutagenicity assays, Structure-Activity Relationship studies, root cause investigations and
extrapolation of Acceptable Intake limits from other substances, according to the highlights. Details are included in the following slides.
@Yosukemino thanks for sharing the documents from The Nitrosamine Implementation Oversight Group.
The statistic shared really got my attention:
- On the call for review requiring the evaluation of a potential risk of the presence of nitrosamines. For centrally authorized products (CAPs), the response was 98% for chemical medicines & 82% for Biological medicines
- All products for which a potential risk of nitrosamines contamination was identified are now going through the confirmatory testing phase. This corresponds to 16% of CAPs with chemical API for which a response is expected by September 2022 and 1% of CAPs with biological API for which a response is expected by July 2023
@jbercu @AndyTeasdale were among industry participants representing EFPIA
Tagging community members for awareness of these important highlights @trust_user_a @trust_user_b
I Agree. Really interesting discussions in the group. SAR refinement for drug-nitrosamine complex will be crucial area. Also, how crucial is the proper conduct of the in vitro Ames test is highlighted in the discussion.