WHO Expert Committee working on a regulatory framework for human cells and tissues and for advanced therapy medicinal products
Pierre Mermet-Bouvier
eCOAs I Regulatory Affairs I Transparency I PMO I Regulatory Intelligence I Clinical Operations I Global and Transversal Teams I Process Improvement I Operational Excellence I Strategic Planning
As seen in the seventy-sixth report of its Expert Committee on Biological Standardization (ECBS) released end of last week, WHO is working on "Considerations in developing a regulatory framework for human cells and tissues and for advanced therapy medicinal products" (page 20).
The Seventy-sixth meeting was held virtually 24-28Oct22.
"There is currently a lack of harmonization between countries and regions. Regulatory oversight is crucially needed to encompass both immediate risks (such as infection) and longer term risks (such as oncogenic potential)."
A revised outcome document was planned to be discussed at its next (already past) meeting in Mar23 ;-)
Stay tuned.