Energy Policy, Journal Year: 2024, Volume and Issue: 198, P. 114467 - 114467
Published: Dec. 16, 2024
Language: Английский
Energy Policy, Journal Year: 2024, Volume and Issue: 198, P. 114467 - 114467
Published: Dec. 16, 2024
Language: Английский
International Journal of Hydrogen Energy, Journal Year: 2025, Volume and Issue: unknown
Published: March 1, 2025
Language: Английский
Citations
0Energy Sources Part B Economics Planning and Policy, Journal Year: 2025, Volume and Issue: 20(1)
Published: April 22, 2025
Language: Английский
Citations
0Personalized Medicine, Journal Year: 2025, Volume and Issue: unknown, P. 1 - 11
Published: April 25, 2025
Advanced Therapy Medicinal Products (ATMPs), which include gene therapies, somatic cell and tissue-engineered products, are a new paradigm for treating previously intractable diseases. Their regenerative personalized approach makes them, unlike conventional treatments, require changing regulatory systems to adjust their intricacies. This review gives comprehensive critique of international programs that the FDA's RMAT designation, EMA's PRIME program, Japan's Sakigake program intended bring ATMPs patients faster while ensuring patient safety. It also considers innovation-led strategies like adaptive licensing, rolling reviews, real-world evidence (RWE) led decision-making pre-market authorization post-market monitoring. In addition, it discusses problems divergence, intricate manufacturing standards, price constraints, transformative role digital technologies such as artificial intelligence blockchain in traceability compliance. Patient-centric models early access schemes extensively debated part parcel future science. To achieve maximum potential across world, need be harmonized responsive, involving real-time data analysis, flexible approval processes, improved stakeholder cooperation. New technologies, coupled with more engagement global convergence efforts, crucial providing equal effective safe advanced therapies.
Language: Английский
Citations
0Heliyon, Journal Year: 2024, Volume and Issue: 10(17), P. e36937 - e36937
Published: Sept. 1, 2024
Language: Английский
Citations
2Results in Engineering, Journal Year: 2024, Volume and Issue: unknown, P. 103743 - 103743
Published: Dec. 1, 2024
Language: Английский
Citations
2Results in Engineering, Journal Year: 2024, Volume and Issue: 24, P. 103117 - 103117
Published: Oct. 12, 2024
Language: Английский
Citations
0Energy Policy, Journal Year: 2024, Volume and Issue: 198, P. 114467 - 114467
Published: Dec. 16, 2024
Language: Английский
Citations
0