Dears,
Have you received requests from authorities to submit nitrosamines risk assessment for topical pharmaceutical products?
If yes, what’s the rational of this request? Are there any guidance or related publications?
Deer @Alaaelkazak
Yes, we received such questions even in the case of shampoos, the agencies refer to the following sentence from the Q10 of EMA/409815/2020
“The same risk approach is applicable to all routes of administration. Corrections to limits are generally not acceptable unless route-specific differences are justified by data.”
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Really thanks dear for the prompt response.
Really thanks dear for the prompt
Hello @Rafa,
Thank you very much for sharing this information.
Could you please share how did you address this request? Did you accept the agency`s requirement and performed analysis on your product?