Global Comparison of Gene and Cell Therapy Regulations: A Cross-Regional Analysis of FDA, EMA, TGA, CSFDA, DCGI, PMDA, IFDA and MFDS
Seyed Heidar Mohammadi1, Gholamhossein Sadeghian1, Hoseein Shomali1, Mohamadreza Abedi1, Behrooz Jannat2, Faham Khamesipour2★★ Corresponding author
- 1Iran Food and Drug Administration, Ministry of Health and Medical Education, Tehran, IRAN.
- 2Food and Drug Research Center, Food and Drug Administration, Ministry of Health and Medical Education, Tehran, IRAN.
CORRESPONDENCE
Faham Khamesipour
Food and Drug Research Center, Food and Drug Administration, Ministry of Health and Medical Education, Tehran, IRAN.
Received: 06-05-2025; Revised: 19-06-2025; Accepted: 25-08-2025.
Volume 60, Issue 1S · pp. s18–s32 · PUBLISHED · DOI: 10.5530/ijper.20260001
ABSTRACT
Gene and cell therapies mark a transformative step forward in treating diseases such as cancer, genetic disorders and autoimmune conditions. However, regulatory pathways for these therapies differ worldwide, impacting approval timelines and patient access. This study aims to conduct a cross-regional comparison of the regulatory frameworks for gene and cell therapies across major health agencies, identifying commonalities, differences and opportunities for harmonization. A comparative review of regulatory frameworks, fast-track designations, approval processes and reimbursement strategies was conducted across eight leading agencies: FDA, EMA, TGA, CSFDA, DCGI, PMDA, IFDA and MFDS. The analysis revealed key differences in therapy definitions, fast-track pathways, approval requirements and post-market surveillance practices, with challenges in streamlining approvals and ensuring long-term safety. Common hurdles include varying definitions of gene and cell therapies, differences in clinical trial requirements and inconsistencies in post-approval monitoring. Areas for global regulatory harmonization include aligning definitions, enhancing collaboration on safety data and developing standardized fast-track pathways. These efforts could accelerate market access while upholding patient safety and transparency.
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Mohammadi, S. H., Sadeghian, G., Shomali, H., Abedi, M., Jannat, B., & Khamesipour, F. (). Global Comparison of Gene and Cell Therapy Regulations: A Cross-Regional Analysis of FDA, EMA, TGA, CSFDA, DCGI, PMDA, IFDA and MFDS. Indian Journal of Pharmaceutical Education and Research, 60(1S), s18–s32. https://doi.org/10.5530/ijper.20260001