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 improved in vitro assays for phototoxicity and genotoxicity
- Enforcement of harmonised protocols across all ICH/VICH regions
In recent years we have provided comments on the following guidelines:
- ICH M3(R2): Guidance on Non clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals
- ICH S1 (R1): Rodent Carcinogenicity Studies for human pharmaceuticals ICH S2 (R1): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use
- ICH S5 (R31): Detection of Toxicity to Reproduction for Human Pharmaceuticals
- ICH S6 (R1): Preclinical Evaluation of Biotechnology Derived Pharmaceuticals
- ICH S9: Non-clinical Evaluation of Anticancer Pharmaceuticals
- ICH S10: Photosafety Evaluation of Pharmaceuticals
- VICH GL47: Guideline On Studies To Evaluate The Metabolism And Residue Kinetics Of Veterinary Drugs In Food-Producing Animals: laboratory animal comparative metabolism studies
- VICH GL46: Guideline On Studies To Evaluate The Metabolism And Residue Kinetics Of Veterinary Drugs In Food-Producing Animals: Metabolism Study To Determine The Quantity And Identify The Nature Of Residues.
- VICH GL48: Guideline On Studies To Evaluate The Metabolism And Residue Kinetics Of Veterinary Drugs In Food-Producing Animals: Marker Residue Depletion Studies To Establish Product Withdrawal Periods
- 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
We have been instrumentation in encouraging reference to the 3Rs in new guidelines as well as improvements to specific aspects of guidelines to replace, reduce and refine animal tests. Our comments also serve to improve the clarity and usability of the guidelines.
Following the deletion of the need for specific acute toxicity tests prior to clinical trials (in ICH M3(R2)), ICAPPP was successful in encouraging the European Medicines Agency to remove its regional guideline specifying acute test in two species, saving approximately 50,000 animals over the following 10 years.
Members of ICAPPP were also instrumentation in encouraging the formation of a dedicated committee at the European Medicines Agency on the 3Rs (the JEG43Rs in 2010, now J3Rs working group). One of their first projects was a review of all their guidelines to see if improvements in line with the 3Rs could be made as well as ensuring all Agency approved authorisations were up to date with respect to the deletion of the rabbit pyrogen test, where applicable.