Introduction to the spotlight to cell therapy regulation
Cell therapy regulation is the topic of a 2-month focus on RegMedNet, featuring a variety of content types and covering various key topics and issues in the field, including the challenges, trends, developments and debates in the regulation of cell therapies aimed at regenerative medicine applications.
Cell therapy is a fast-developing field with the potential to have a transformative effect on healthcare. However, cells carry significant potential risks and therefore need careful and regulated investigation and application, to ensure practice is effective, safe and ethical.
Regulatory agencies such as the US FDA, EMA and PMDA aim to facilitate development of safe and effective products, but must keep their policies up to date with the advancement of technology, and balance patient safety versus getting treatments to those in need faster.
Furthermore, there is a lack of harmonization of global regulatory regimens: the Japanese government recently set more flexible and relaxed regulations to advance stem cell-based therapies to market by allowing conditional marketing authorization, but regulation in other countries remains stricter.
This spotlight on cell therapy regulation will aim to provide insight into challenges, trends, developments and debates in the regulation of cell therapies aimed at regenerative medicine applications. We will explore topics such as how policies differ globally, the challenge of steering through the regulatory landscape for both academic researchers and manufacturers, and the number of unproven cell therapies being advertised on the market.
- Join experts from Assymetrex, Cryoport, the Cell and Gene Therapy Catapult and the Centre for the Commercialization - register now!
- Food for thought: the US FDA and the development of regenerative medicine products
- The commercialization of cell and gene therapies: regulatory challenges
- The Regulation of Clinical Stem Cell Research and Applications: three dynamics of global regulatory diversification (part 1)
- The Regulation of Clinical Stem Cell Research and Applications: three dynamics of global regulatory diversification (part 2)
- Safeguarding standards at the UK Stem Cell Bank: an interview with Glyn Stacey
- Lessons for accelerating the stem cell and regenerative medicine industry
- Exclusive Industry Updates from Regenerative Medicine Editorial Boardmember and RegMedNet leader Dusko Ilic covering the latest news in Clinical Trials, Business Development, Capital Market and Finances, and Regulations, Approvals and Acquisitions.
- Regulatory requirements in the good manufacturing practice production of an epithelial cell graft for ocular surface reconstruction
- Opening the gateways to market and adoption of regenerative medicine? The UK case in context
- The translation of cell-based therapies: clinical landscape and manufacturing challenges
- The current status of clinics providing private practice cell therapy in Japan
- Bringing regenerative medicines to the clinic: the future for regulation and reimbursement
- Autologous cell therapies: challenges in US FDA regulation
- Canada’s emerging cell therapy biotech industry
- Novadip gets financing for cell therapy
- China battles rogue stem cell research
- Advanced-economy nations top global distribution of businesses marketing stem cell therapies
- Australian authorities to tackle unproven stem cell treatments
- Japanese Pharmaceutical & Medical Devices Agency
- Retinitis pigmentosa cell therapy receives Regenerative Medicine Advanced Therapy designation
- C-Cure®, from Celyad, is designed to enhance the reparative capabilities of the heart and will shortly be the focus of a Phase III pivotal study