Over the past few years, the regulatory landscape for cell therapy development has grown increasingly complex. There are now accelerated pathways for Advanced Therapy Medicinal Products (ATMPs) in several countries worldwide, including the U.S., Japan, and South Korea.
Legislation took effect in Japan in late 2014, in South Korea in 2016, and in the United States in 2017.
Additionally, the EU has a program for product acceleration – the Adaptive Pathways.
While the possibility for accelerated commercialization has resulted from these changes, substantial complexity has also been introduced, making it a more elaborate process to move cell therapy products from “bench to bedside.”
For this reason, BioInformant has released a 14-page guide that takes the complex global environment for cell and gene therapies and synthesizes it into a clear and concise market brief.
Claim it to:
- Understand accelerated pathways for ATMPs within leading markets worldwide
- Recognize the role of Japan as a “gateway” country for cell and gene therapy commercialization
- Reveal key provisions within the 21st Century Cures Act (and its differences from the REGROW Act)
- Identify the companies, products, and indications issued RMAT Designations
- Understand the four guidance documents defining the FDA’s framework for cell and gene therapy regulation
For a limited-time, you can claim the guide for only $27 and get access for life (no user license required)
Of course, your investment is also backed by a 60-Day Money Back Guarantee.