Development and data requirements of potency tests for cell-based therapy products and the relation to clinical efficacy - Scientific guideline

This document reflects the need for a guideline on the development and data requirements of potency tests for cell-based therapy products and the relation to clinical efficacy. The scope of the guideline is to give clear advice to applicants and assessors on the development of potency tests for cell-based therapy products as well as validation of analytical methods used for potency assays.

Keywords: Novel therapies, cell therapies, cell-based, clinical efficacy, potency, mechanism of action, investigational cell-based products, new veterinary regulation