Considerations in developing a regulatory framework for human cells and tissues and for advance therapy medicinal products, Annex 3, TRS 1048

27 May 2023

| Technical document

Overview

The current document represents a further step in responding to resolution WHA67.20 (26), and to the above recommendations of the WHO Expert Committee on Biological Standardization (27–29) and the 2018 ICDRA (31). By outlining a number of fundamental principles and concepts in the regulatory oversight of different types of HCTs and ATMPs, the document is intended to advance and promote both regulatory convergence and the practice of regulatory reliance across all jurisdictions – whether or not adequate regulations are currently in place. It is intended that this will in turn facilitate both the development of and access to advanced medicinal products. The document also outlines a number of priorities in harmonizing regulatory frameworks in order to improve product safety, ensure efficacy, and

prevent the exploitation of donors and patients. In this regard, the document also serves to highlight the crucial importance of strengthening national regulatory systems for the oversight of these vitally needed medicinal products.

WHO Team

Health Product Policy and Standards (HPS), Norms and Standards for Biological Products (NSB), Technical Standards and Specifications (TSS)

Number of pages

101

World Health Organization CC BY-NC-SA 3.0 IGO