Tissue Engineered Products – Pharmacy Institutional Readiness Guidance

A Tissue Engineered Product consists of / or contains engineered cells or tissues and is used in or administered to human beings with a view to regenerating, repairing, or replacing a human tissue.

TEPs are classed as ATMPs and as such, Pharmacy oversight is required even when they are not handled within Pharmacy.

The purpose of this document is to outline the key areas where chief pharmacists should focus pharmaceutical expertise prior to an organisation implementing any Tissue Engineered Product.

This document presents a flow diagram outlining a stepwise approach to implementing Tissue Engineered Products. It is followed by checklists.