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

Current version

Guideline on the development and data requirements of potency tests for veterinary cell-based therapy products and the relation to clinical efficacy

Adopted Reference Number: EMA/CVMP/NTWP/179287/2022 Legal effective date: 23/06/2023

Document history

Guideline on the development and data requirements of potency tests for veterinary cell-based therapy products and the relation to clinical efficacy

Adopted Reference Number: EMA/CVMP/NTWP/179287/2022 Legal effective date: 23/06/2023

Overview of comments received on 'Guideline on the development and data requirements of potency tests for veterinary cell-based therapy products and the relation to clinical efficacy ' (EMA/CVMP/NTWP/179287/2022)

Adopted Reference Number: EMA/NTWP/85029/2023

Draft guideline on the development and data requirements of potency tests for cell-based therapy products and the relation to clinical efficacy

Draft: consultation closed Consultation dates: 18/11/2022 to 28/02/2023 Reference Number: EMA/CVMP/NTWP/179287/2022 Summary:

The aim of this guideline is to provide guidance on the requirements for developing and implementing a suitable potency assay or a combination of assays, which is linked to relevant biological properties of the cell-based product and further to clinical efficacy.

Concept paper on the development and data requirements of potency tests for cell-based therapy products and the relation to clinical efficacy

Draft: consultation closed Consultation dates: 28/01/2022 to 29/04/2022 Reference Number: EMA/CVMP/NTWP/470741/2021 Summary: