The revised ICH Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals S5(R3) has now been released to the regulatory bodies of ICH regions (“step 4”) for adoption. The S5(R2) Guideline was written over 20 years ago. This revision aims to incorporate experiences gained from the testing of pharmaceuticals, as well as advances in scientific, technological and regulatory knowledge. Furthermore, it attempts to provide greater clarity and alignment with other ICH Guidelines, including ICH M3(R2), ICH S6(R1) and ICH S9.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (2020). ICH Harmonised Guideline. Detection of reproductive and developmental toxicity for human pharmaceuticals S5(R3). Final version. Adopted on 18 February 2020.


The above items were taken from the April 2020 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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