Many cell and gene therapy products use special delivery devices. Generally, there are two approaches for development and commercialization. 1: specify a device brand in the label to be used with the cell or gene therapy products. Under this approach, the sponsor is developing a drug/device combination product, need to navigate complex, often rather different, regulatory pathways in different countries, regions. 2: not to specify a brand but only describe device characteristics so that end users can source the device on their own to the defined characteristics. Under this approach, the sponsor needs to consider data required to support drug compatibility with potentially a class of device products. The US FDA has issued a guidance in 2019 on CGTP delivery devices. In the EU, regulatory requirements differ between integral, non-integral co-packaged, or not co-packaged (e.g. referenced) medical devices. In addition, distinct legislative frameworks for medicinal products and medical devices require joint input of respective experts.
This session will use case studies to explore and discuss each approach, share lessons learned during early and late stage CGTP development on managing regulatory procedures, overcoming regulatory hurdles.
The Regulatory Interface of ATMPs and Medical Devices in Europe
Ilona Reischl, Austrian Medicines and Medical Devices Agency
U.S. FDA’s Perspective on Delivery Devices Used to Administer Cell and Gene Therapy Products
Laura Ricles, CBER, FDA
What Device Engineers Can Teach You About CGTP Delivery Devices