Why LTL approach is not been considered?

Mrunal · May 13, 2021, 4:26am

Resharing the below message:

Hello @Nitesh, how are you? Thanks for sharing your valuable insights.
For your question related to ONCO products, you can refer to EMA/369136/2020 ‘Committee for Medicinal Products for Human Use (CHMP)’ published on 25 June 2020 (Recommendations section: point no. 6), which is as follows:
“Exceptions to sections 3. and 4. include some products falling outside the scope of the ICH
M7(R1) guideline, i.e. certain active substances and finished products intended for advanced
cancer indications or when the active substance is itself genotoxic. For finished products
intended only for advanced cancer, N-nitrosamine impurities should be controlled according to ICH Q3 A(R2) and ICH Q3B(R2), as specified in the Q&A document to ICH S9. When the active substance itself is genotoxic at therapeutic concentrations, N-nitrosamine impurities could be controlled at limits for non-mutagenic impurities according to ICH M7(R1)”.
nitrosamines-emea-h-a53-1490-assessment-report_en.pdf (1.3 MB)

You can also refer to ‘EMA/409815/2020 Rev.1’ Qand A published on 29 January 2021.
2004-referral-nitrosamine-impurities-human-medicinal-products_en.pdf (499.7 KB)

How do you consider this approach?