Use of tumorigenic cells of human origin for the production of biological and biotechnological medicinal products - Scientific guideline

This document sets out the current EU regulatory thinking with regard to risk assessment of the purified products derived from tumourigenic cells. It is not legally binding on applicants and may evolve with new scientific developmnets.

Keywords: Biotechnological product, biological product, tumorigenic cell, residual cell DNA

Current effective version

Position statement on the use of tumourigenic cells of human origin for the production of biological and biotechnological medicinal products

Adopted Reference Number: CPMP/BWP/1143/00 Legal effective date: 27/02/2001