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Companies face different regulatory requirements in Europe, United States for cell therapies
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MIAMI — The regulatory environments of the United States and European Union present distinct challenges for companies developing autologous cell therapy solutions for cartilage repair.
Michael Halpin, vice president of regulatory affairs for Genzyme, detailed the current challenges for industry and presented recommendations for resolving these issues.
“If you look at these regulations, you will see that they are all evolving as cell therapies are evolving and new products are being brought into the market,” Halpin said at the 8th World Congress of the International Cartilage Repair Society, here. “However, they are not necessarily harmonized. Sometimes [companies] may have to meet different requirements for the same purpose in different countries.”
Cartilage cell repair therapies differ and can be patient-specific. They are local therapies and cross the traditional product categories of pharmaceutics, biologics, and device and tissue bank registries.
“Complex surgical clinical trials and designs may be required for some of these products, and there may be some nonstandard designs based on these types of products, including the inability to double-blind patients in some situations,” Halpin said.
He said the harmonization of evolving regulations and flexible development of products are effective approaches for confronting these challenges. Providing consistent, standard requirements for sponsors, consistent manufacturing requirements, easier importation and exportation of approved materials, and avoiding repetitive data collection are ways to harmonize evolving regulations, Halpin added.
The flexible development of these products can be achieved through the use of experts and guidance documents, he said.
“Adapting systematic therapy-based regulation for applicability to local-effect products could be helpful, [and] clinical trial requirements should balance scientific rigor and feasibility,” Halpin said. In addition, regulatory agencies could develop a risk-based approach to recognize incremental improvements.
Reference:
- Halpin M. An industry perspective on the E.U. and U.S. regulatory requirements for autologous cell therapy solutions for cartilage repair. #2.3.3. Session 2.3: Regulatory issues in cartilage repair. Presented at the 8th World Congress of the International Cartilage Repair Society. May 23-26, 2009. Miami.