Regulatory Convergence in Cell and Gene Therapy: Harmonizing Quality, CMC, and Approval Pathways Across the FDA, EMA, PMDA, and Emerging Markets

Nagendra Verma, Swati Arora

Open source

DOI
10.3390/biotech15040079
Published
2026-09-16
Container
BioTech
Publisher
MDPI AG
Open access
unknown

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BibTeX

@article{allodium:10.3390/biotech15040079,
  title = {Regulatory Convergence in Cell and Gene Therapy: Harmonizing Quality, CMC, and Approval Pathways Across the FDA, EMA, PMDA, and Emerging Markets},
  author = {Nagendra Verma and Swati Arora},
  year = {2026},
  journal = {BioTech},
  doi = {10.3390/biotech15040079},
  url = {https://doi.org/10.3390/biotech15040079}
}

RIS

TY  - JOUR
TI  - Regulatory Convergence in Cell and Gene Therapy: Harmonizing Quality, CMC, and Approval Pathways Across the FDA, EMA, PMDA, and Emerging Markets
AU  - Nagendra Verma
AU  - Swati Arora
PY  - 2026
JO  - BioTech
DO  - 10.3390/biotech15040079
UR  - https://doi.org/10.3390/biotech15040079
ER  - 

APA

Verma, N., & Arora, S. (2026). Regulatory Convergence in Cell and Gene Therapy: Harmonizing Quality, CMC, and Approval Pathways Across the FDA, EMA, PMDA, and Emerging Markets. BioTech. https://doi.org/10.3390/biotech15040079

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