Pharmas want ICH to streamline toxicity requirements for severe diseases

Pharmas have embarked on the long road to developing new ICH guidelines that could expedite patient access to therapies for severe or life threatening diseases by up to three years, calling upon advanced cancer guidance as a model.

The proposed guideline would eliminate or defer to the post-market setting some preclinical toxicity testing, like pharmacology safety, carcinogenicity and fertility tox studies, while shortening the duration of others, like general toxicology tests. ...