title: Impact analysis of ICH S9 on non-clinical development of anticancer drugs.
abstract: Cancer presents a major healthcare challenge worldwide, with several millions new cases a year, and represents a therapeutic area with a high need for new drugs. To respond to this, the parties of the International Conference for Harmonization agreed in 2007 to develop a guideline on nonclinical requirements for oncology therapeutics' development (ICH S9), which came into effect in early 2010. This guideline includes recommendations to facilitate and accelerate the development and marketing of cancer therapeutic agents for serious and life threatening malignancies and aims to address this need through a refinement and a reduction in the use of experimental animals, following the 3Rs principles. To assess the impact of ICH S9 on drug development and reduction of animal use, we performed an analysis of Marketing Authorization Applications at the European Medicines Agency relevant to the period in which the development of the guideline was approaching the final steps and its early implementation period. From the analysis performed, a consistent trend towards a decrease in the average number of non-clinical studies performed (-40.7%) and number of animals used per development program (-58.1%) for new chemical entities has been detected, highlighting increasing compliance by companies to the recommendations of ICH S9.
authors.affiliation: European Medicines Agency (EMA), 30 Churchill Place, E3 2PY, London, UK. Electronic address: Milton.Bonelli@ema.europa.eu.
authors.forename: Milton
authors.initials: M
authors.lastname: Bonelli
authors.affiliation: Government Affairs & Strategic Health Initiatives Analyst, AbbVie, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Di Giuseppe
authors.affiliation: Belgian Federal Agency for Medicines and Health Products, also Chair of EMA Joint Expert Group on 3Rs, Belgium.
authors.forename: Sonja
authors.initials: S
authors.lastname: Beken
mesh_terms: D032761:Animal Experimentation / Q000592:standards; D000818:Animals; D000830:Animals, Laboratory; D000970:Antineoplastic Agents / Q000494:pharmacology* / Q000592:standards*; D017277:Drug Approval / Q000379:methods; D055808:Drug Discovery / Q000592:standards*; D004345:Drug Industry / Q000379:methods; D017408:Guidelines as Topic; D007391:International Cooperation; D009369:Neoplasms / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents
keywords: 3Rs; Animal welfare; Cancer; Centralised procedure; Drug development; EMA; ICH S9; International Conference for Harmonisation; Oncology