• Regulatory NewsRegulatory News

    ICH signs off on carcinogenicity testing addendum

    The International Council for Harmonisation (ICH) recently announced that its S1B(R1) addendum outlining a “weight of evidence” (WoE) approach to assess the human carcinogenic risk for certain pharmaceuticals in lieu of conducting a two-year rat study has reached Step 4 and is awaiting sign-off by regulators.   The document contains several changes from the Step 2 guideline released in May 2021. (RELATED: To speed drug development, ICH proposes reducing rat carcinoge...
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    ICH reports “significant milestones” reached on guidelines ranging from impurity testing to eCTD standards

    The International Council for Harmonisation (ICH) has reported that “significant milestones” were reached over the past year in the adoption of guidelines on residual solvent testing, carcinogenicity testing, and specifications for submitting applications in the electronic Common Technical Document (eCTD).   ICH made this 10 June announcement following a virtual meeting of the ICH Assembly. During the meeting, the ICH Assembly adopted several guidelines for Step 4 of t...
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    To speed drug development, ICH proposes reducing rat carcinogenicity testing

    The International Council for Harmonisation (ICH) recently announced a new draft guideline that proposes a “weight of evidence” approach to inform whether a two-year rat study would add value in evaluating a drug’s carcinogenic risks.   The proposed guideline provides more detailed guidance for drug developers who are considering whether rodent studies are needed to assess carcinogenicity. The ICH S1B(R1) addendum, once adopted, should be used in conjunction with the I...
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    On Eliminating Two-Year Rat Carcinogenicity Studies for Pharma: ICH Seeks More Data

    The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) will continue to study for two more years whether guidance can be revised on certain situations when sponsors will not have to conduct and submit a two-year rat carcinogenicity study for a developing drug. In order to test the feasibility of eliminating such studies in some cases, which would be part of revisions to ICH’s S1 Guideline , ICH began collecting vol...
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    Rodent Carcinogenicity Testing: Changes to ICH Guidance Proposed

    The European Medicines Agency (EMA) is considering changes to International Council for Harmonisation (ICH) guidance on rodent carcinogenicity testing to improve the evaluations, reduce use of animals and drug development resources and reduce timelines to market authorization in some cases without compromising patient safety. The goal of the potential changes to the S1 guidance, according to EMA, is to introduce a better way to address the risk of human carcinogenicity o...
  • Feature ArticlesFeature Articles

    Can Rodent Carcinogenicity Testing Be Eliminated?

    The International Conference on Harmonisation (ICH) Steering Committee has endorsed a concept paper that supports reviewing and harmonizing requirements for carcinogenicity testing in rodents (Topic S1). 1 In line with the 3Rs principle (reduction, replacement and refinement - a major principle of the ICH harmonisation process), the paper suggests it may be possible to reduce or eliminate the need for such testing in a significant number of cases. Such an outcome could ...
  • ICH Looking to Establish New Harmonized Guideline on Carcinogenicity Testing

    The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) announced 14 May it has established a concept paper and business paper for a new expert working group (EWG) aiming to develop guidance on rodent carcinogenicity testing. "The aim of this new topic is to introduce a more comprehensive and integrated approach to addressing the risk of human carcinogenicity of pharmaceuticals, and also to clar...