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Updated: Apr 6, 2026

Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo
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Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo

Published on: February 6, 2015

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Impact analysis of ICH S9 on non-clinical development of anticancer drugs

Milton Bonelli1, Francesca Di Giuseppe2, Sonja Beken3

  • 1European Medicines Agency (EMA), 30 Churchill Place, E3 2PY, London, UK.

Regulatory Toxicology and Pharmacology : RTP
|August 2, 2015
PubMed

Insights

The International Council for Harmonisation S9 guideline reduced animal testing in oncology drug development. New chemical entity programs saw a 40.7% decrease in non-clinical studies and a 58.1% drop in animal use.

Area of Science:

  • Oncology
  • Drug Development
  • Regulatory Science

Background:

  • Cancer is a global health challenge requiring novel therapeutics.
  • The International Council for Harmonisation S9 guideline was developed to streamline oncology drug development.
  • The guideline promotes the 3Rs principles (Replacement, Reduction, Refinement) to minimize animal use.

Purpose of the Study:

  • To evaluate the impact of the International Council for Harmonisation S9 guideline on non-clinical study requirements and animal usage in oncology drug development.
  • To assess the adoption of ICH S9 recommendations by pharmaceutical companies.

Main Methods:

  • Analysis of Marketing Authorization Applications submitted to the European Medicines Agency.
  • Comparison of non-clinical study numbers and animal usage before and after ICH S9 implementation.
  • Focus on new chemical entities for oncology therapeutics.

Main Results:

  • A significant decrease in the average number of non-clinical studies per development program (-40.7%).
  • A substantial reduction in the average number of animals used per development program (-58.1%).
  • Evidence of increasing industry compliance with ICH S9 recommendations.

Conclusions:

  • The ICH S9 guideline has successfully reduced the extent of non-clinical testing and animal use in oncology drug development.
  • The guideline facilitates faster development and marketing of life-saving cancer therapeutics.
  • Continued adherence to ICH S9 is expected to further optimize drug development processes and animal welfare.
Keywords:
3RsAnimal welfareCancerCentralised procedureDrug developmentEMAICH S9International Conference for HarmonisationOncology

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