International – ICH announces forthcoming documents on nitrosamine impurities, RWD

The International Council for Harmonisation (ICH) announced plans to issue two new documents: an addendum to the M7 guideline on assessing carcinogenic risk that would establish daily acceptable intake limits (AIs) for nitrosamine impurities and a reflection paper on harmonizing real-world data (RWD) in analyzing drug efficacy.

These developments were announced on 12 June following a 5 June meeting in Fukuoka, Japan. ICH also noted that “significant milestones” had been reached on advancing other guidelines.

Plans are in the works to issue an addendum to the ICH M7(R2) guideline on “Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” to control the safety of nitrosamines through the development of a harmonized set of acceptable intakes (AIs).

The current ICH M7(R1) guideline labels nitrosamines as a “cohort of concern” but does not set daily intake limits for these compounds.

The ICH Assembly also endorsed an upcoming reflection paper, soon to be published, on harmonizing RWD to generate real-world evidence, with a focus on using this data to measure drug effectiveness. The paper will accommodate public comments received during a consultation held June-September 2023…