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Posted 20 August 2020 | By Kari Oakes 

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 In February 2019, the US Food and Drug Administration issued a draft guidance of the S11 document for consultation as well.
The guidance excludes tissue engineered products, gene and cellular therapies and vaccines from its scope. In crafting the nonclinical safety testing guidance, ICH had dual goals of achieving the conduct of pediatric clinical trials in timely fashion, as well as reducing the use of animals in nonclinical testing when possible. A “weight-of-evidence” approach is used in the guidance to aid sponsors and researchers in ascertaining when toxicity studies might be conducted in juvenile animals.
The weight-of-evidence approach takes several factors into consideration when making decisions about nonclinical safety testing for pediatric drug development. Available clinical and nonclinical data as well as pharmacological and pharmacokinetic data should all factor in when sponsors are considering what safety testing is necessary.
Factors increasing the likelihood for further studies being needed include younger age of intended patients, greater effect on developing organs systems, whether the pharmacological target has a role in organ development, and the duration of treatment. Less existing data and low selectivity and specificity of the studied pharmaceutical product also increase the likelihood that more studies will be needed, according to the weight-of-evidence schema.
The ICH S11 guideline also addresses situations where pediatric drug development might be the first or only avenue for a product. Excipient considerations and combination drug scenarios are also detailed in the guidance.


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