ICH M7 plans to harmonize AI limits for Nitrosamines

Following the recent ICH meeting on 5 June in Fukuoka, Japan, the ICH has announced plans to release an addendum to the M7 guideline focused on establishing acceptable intake (AI) limits for nitrosamine impurities.

The forthcoming addendum to the ICH M7(R2) guideline aims to develop a unified approach to determining acceptable intake limits for nitrosamines.

Lets hope the harmonized approach from ICH is more relevant from patient safety perspective rather than going all out conservative as it is now.

Interested to hear from the community member’s their perspective on harmonizing AI limits.



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