Current Programmes

We are largely reactive to developments at the ICH and VICH; however we have an ongoing particular interest in:

  • Deletion of redundant quality control methods involving animals, including pyrogenicity, abnormal toxicity and target animal (batch) safety tests
  • Deletion of redundant safety tests involving animals, including acute toxicity, carcinogenicity and second species tests
  • Promotion of language in all testing guidelines that prioritises the use of non-animal methods and other efforts to reduce and refine animal testing
  • Enforcement of harmonised protocols across all ICH/VICH regions

Some examples of guidelines we have commented on include:

Human (ICH)

  • ICH S3A: Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies – Q&A
  • ICH S5 (R31): Detection of toxicity to reproduction for human pharmaceuticals
  • ICH S11: Nonclinical safety testing in support of development of paediatric medicines
  • ICH S12: Nonclinical biodistribution considerations for gene therapy products
  • ICH S1B: Addendum to the guideline on testing for carcinogenicity of pharmaceuticals

Veterinary (VICH)

  • VICH GL50: Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use
  • VICH GL55: Harmonisation of criteria to waive target animal batch safety testing for live vaccines for veterinary use
  • VICH GL59: Harmonisation of criteria to waive laboratory animal batch safety testing (LABST) for vaccines for veterinary use
  • VICH GL7: Efficacy of anthelmintics: general requirements

For many of these guidelines, our comments led to important changes including improved language on the prioritisation of non-animal methods and the 3Rs principles, clarification on how alternative methods can be used and the deletion of language that promoted cruel or redundant animal tests.

We also participate in regular public meetings, including the US FDA and Health Canada’s biennial regional ICH public consultation meetings, and provide feedback through presentations, wherever possible, and oral/written comments.