Thank you Naiffer for summarising again the MHRA nitrosamine context.
When this guideline came first out in the summer (the 2 August publications), you commented:
“Overall, this update adds very little to the already available guidelines. It provides information on the temporary use of nitrosamines exceeding AIs. It notes the need to contact the Defective Medicines Report Center. Still, the MHRA remains silent on NDSRIs and how they would be tackled from the regulatory perspective, aside from referring to ICH and EMA guidelines. Additional details are likely forthcoming.”
MHRA publishes guidelines for Nitrosamine Impurities - Guidance, Documents, Resources - Nitrosamines Exchange (usp.org)What are your insights today, is that very high level Q&A now the final Q&A document or is clearer guidance from MHRA still forthcoming?
We know ICH M7 and EMA nitrosamine guidance are not always leading to the same conclusion, so I would be interested to understand if and how the endorsement of CPCA by MHRA will start to affect previous MHRA decisions.
Does anybody here have practical experience on how MHRA is currently dealing with the Appendix 1 from the EMA Q&A 10? Any retractions by the agency of previously approved limits which were not CPCA-based and/or are higher than Appendix 1 published AIs?