Canada – Health Canada adopts ICH pediatric drug development guidance

Health Canada is implementing a guidance for nonclinical safety testing to support pediatric medication development.
The guidance was developed by the International Council for Harmonization of Technical Requirements of Pharmaceuticals for Human Use (ICH), and carries the title Guidance S11: Nonclinical Safety Testing in Support of Development of Pediatric Medicines. The Canadian guidance is being fully implemented without modifications, a commitment Health Canada has made as a standing member of ICH.
The S11 guidance has also been adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) with implementation slated for 26 September 2020. In February 2019, the US Food and Drug Administration issued a draft guidance of the S11 document for consultation as well…