Eddie Tan, PhD CABP (Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore)
Vorapin Chinchalongporn, PhD (SC21 Bio-Pharma Laboratories, Thailand)
Fajar Dumadi (International Society for Cell & Gene Therapy, Canada)
Zlatibor Velickovic, PhD (Cell & Tissue Therapies WA, Royal Perth Hospital, Australia; University of Western Australia, Australia)
Janet Macpherson, PhD (NSW Health Pathology, Sydney, Australia)
William (Bill) Milligan (Steminent Biotherapeutics Inc., Taiwan)
On behalf of ISCT Asia Pacific (APAC) Industry Committee
The Asia Pacific (APAC) region is emerging as a powerhouse of cell and gene therapy (CGT). Significant investments, advanced research, and clinical development infrastructure are fueling rapid growth across the APAC CGT sector. This growth is driven by strong patient demand, bolstered by the region's large and diverse patient populations, a high incidence of target diseases, thriving innovation ecosystems, and increasing government support and investor interest. Additionally, expanding expertise in CGT research and development and clinical trials creates a fertile ground for CGT clinical development.
Despite these promising dynamics, the APAC region has a complex regulatory environment that poses significant challenges for product developers wishing to advance their product candidates in multiple regulatory jurisdictions. Each country has established its own regulatory frameworks, approval processes, and documentation requirements for CGT products. This regulatory patchwork results in a lack of harmonisation, making it difficult for developers to navigate clinical trial approvals, manufacturing standards, and post-approval changes across borders. Additional logistical issues, such as import/export restrictions on genetic materials, complex documentation, and varying healthcare provider capabilities, compound these challenges.
The ISCT APAC Industry Committee recognises both the immense potential of the APAC region for CGT and the regulatory challenges posed by its diversity. To address these challenges, the committee has undertaken the following initiatives:
● Mapping the regulatory landscape across the leading CGT-active APAC markets, highlighting differences and commonalities in approval pathways, documentation, and compliance standards.
● Providing practical guidance for developers on navigating region-specific requirements, with the goal of streamlining multiple jurisdiction filings and product development to accelerate patient access to these innovative therapies.
As a result, the committee recently published its first paper in the series, providing regulatory roadmaps for Japan, Singapore, and South Korea. The paper highlights the jurisdiction-specific regulatory frameworks and provides clear guidance on product marketing authorisation requirements and patient access pathways specific to each jurisdiction.
Following the publication of this initial regulatory roadmap, the committee plans to publish further roadmaps throughout the coming year. These subsequent documents will explore the regulatory frameworks in jurisdictions actively engaged in CGT within the APAC region, including, but not limited to, China, Taiwan, India, Australia, and New Zealand..
The first publication is available on the Cytotherapy website found at the following URL: https://www.isct-cytotherapy.org/article/S1465-3249(25)00590-0/fulltext
If you are interested to know more about our initiatives and/or contribute, please visit:
Asia Pacific Industry Committee: https://www.isctglobal.org/about/isct-committees/apac-industry