To Navigate Global Regulatory Frameworks & Expedited Programs For Gene Therapy Development In The U.S., EU, & Japan

By Naomi Kautz

As scientific knowledge, clinical experience, and acceptance of gene therapy products have evolved, so have the regulatory frameworks for ensuring the safety of these novel treatments. To date, there is no harmonized international standard for regulating gene therapy products; however, the U.S., EU, and Japan have established regulatory frameworks with subtle variations. Understanding how gene therapy products are regulated—and how to navigate regional or national regulatory differences—can help you develop an efficient product development plan to bring your treatment to patients in need.

In this blog post, we review the regulatory frameworks for gene therapies in the U.S., EU, and Japan, with a focus on programs designed to streamline the product development and approval process.