International – ICH reports “significant milestones” reached on guidelines ranging from impurity testing to eCTD standards

The International Council for Harmonisation (ICH) has reported that “significant milestones” were reached over the past year in the adoption of guidelines on residual solvent testing, carcinogenicity testing, and specifications for submitting applications in the electronic Common Technical Document (eCTD).

ICH made this 10 June announcement following a virtual meeting of the ICH Assembly. During the meeting, the ICH Assembly adopted several guidelines for Step 4 of the ICH process, while revising existing guidelines.
ICH noted that these milestone guidelines over the past year include the Step 4 sign-off of the Q3C(R8) guideline on residual solvents, which has been revised to include the permitted daily exposure (PDE) levels for 2-methyltetrahydrofuran, cyclopentyl methyl ether and tertiary butyl alcohol. (RELATED: ICH announces sign-off of residual solvent guidelineRegulatory Focus 3 May 2021)…