Considerations in developing a regulatory framework for human cells and tissues and for advanced therapy medicinal products

Overview

WHO encourages regulatory cooperation and reliance between authorities and other entities involved in the oversight of HCTs and ATMPs. Existing opportunities for joint reviews and inspections, agency visits, collaboration in the reviewing of medicinal products for rare and ultra-rare diseases, regulatory activities based on reliance, and so on could all be further expanded and would positively impact upon the global accessibility of these products. Sharing knowledge, expertise and experience is crucial for strengthening global regulatory capacity for the oversight of HCTs and ATMPs in all regions of the world. For those regulatory authorities now in the process of investing resources in strengthening their regulatory capacity and building up their expertise there would be significant benefits in collaborating with a more experienced regulatory authority.