The ICH S5(R3) guideline on the detection of toxicity to reproduction for human pharmaceuticals has now entered the “consultation period” (step 2b). The guideline provides key considerations in the development of a testing strategy to identify reproductive hazard (and characterise its corresponding risk) for human pharmaceutical products and their components, including biologics, novel constituent ingredients and excipients. The ICH noted that scientific, technological and regulatory knowledge has significantly developed since the previous guideline was published in 2005; consequently there were opportunities for modernising testing strategies to enhance the human risk assessment and also for reducing the use of laboratory animals.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (2017). Draft ICH Harmonised Guideline. Detection of toxicity to reproduction for human pharmaceuticals S5(R3). Current Step 2 draft version. 5 July 2017.


The above items were taken from the October 2017 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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