Regulatory acceptance of 3R’s testing approaches Sample Clauses

Regulatory acceptance of 3R’s testing approaches. ‌ The following criteria should be used before consideration of a 3R’s testing approach for regulatory acceptance: • Availability of defined test methodology including standard protocols with clear defined/scientifically sound endpoints. • Relevance, where relevance describes the relationship of the test method to the effect of interest and whether it is meaningful and useful for a particular purpose (context of use). It is the extent to which the test correctly measures or predicts the biological effect of interest. Relevance incorporates consideration of the accuracy (e.g. concordance with comparable validated test method with established performance standards) of a test method6. 4 xxxxx://xxx.xxx.xxx/drugs/developmentapprovalprocess/default.htm 5 xxxxx://xxx.xxx.xxx/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073246.pdf 6 ICH S1 Regulatory Notice Document (xxxx://xxx.xxx.xxxxxx.xx/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/12/WC5 00136405.pdf).‌ • Context of use includes a description of the circumstances under which the 3R’s testing approach is applicable in the assessment of human medicinal products and the limitations within which the available data adequately support use of the 3R’s testing approach. It should for instance be demonstrated that the new or substitute testing method or testing strategy provides either new data that fill a recognised gap or data that are at least as useful as, and preferably better than those obtained using existing methods. • Reliability/robustness; a measure of the extent that a test method can be performed reproducibly over time and in different laboratories when using the same protocol. While replacement of animal studies remains the ultimate goal, approaches aiming at reducing or refining animal studies are routinely implemented in regulatory guidelines, where applicable. The European Pharmacopoeia also encourages animal-free approaches to be used by manufacturers including, for example, through the proof of consistency to avoid unnecessary tests in animals on intermediate stages of production or on the final product. Alternative methods need to fulfill the ‘fit-for-purpose’ criteria for regulatory acceptance (Xxxxxxxxxx et al. 2016). The above-mentioned criteria can be achieved by (1) qualification of the equipment according to standard installation, operation and performance; (2) meeting the rules of Good Cell Culture Practice and use of qualified cell and tissue...
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