| Abstrakt: |
Astellas Pharma Inc. researchers have conducted a study on the regulatory systems and requirements for clinical trials of adeno-associated virus (AAV)-based gene therapies in six Asian countries or regions: China, India, Japan, Singapore, South Korea, and Taiwan. The study found that there have been fewer AAV-based gene therapy studies conducted in Asia compared to North America and Europe. The researchers provide an overview of the regulatory processes, laws, regulations, guidelines, consultations, and challenges associated with developing gene therapy products in these locations. The study concludes with policy recommendations to simplify the regulatory review and consultation systems and provide training programs and guidance to support the advancement of gene therapy development in Asia. [Extracted from the article] |
