Post-marketing surveillance framework of cell and gene therapy products in the European Union, the United States, Japan, South Korea and China: a comparative study
This study demonstrates that the regulatory policies of PMS for CGTPs in the EU, the US, Japan, and South Korea were comprehensive. The implementation of PMS for CGTPs in the EU, the US, and Japan was well developed. This knowledge holds valuable insights for China's future learning and development in this field.
Authors
- Luyao Gong (ORCID: https://orcid.org/0000-0001-9834-3914)
- Yuan Gao (ORCID: https://orcid.org/0000-0003-3681-0411)
- Jingjing Wang (ORCID: https://orcid.org/0000-0001-6190-3009)
- Weijia Wu (ORCID: https://orcid.org/0000-0003-3912-7212)
- Yeheng Peng
- Yuxin Cai (ORCID: https://orcid.org/0009-0003-2448-8346)
- Weilin Qian
- Lijuan Sui
Institutions
- Fudan University (CN)
- Renji Hospital (CN)
- Zhejiang University (CN)
Publication Details
- Journal
- BMC Medicine
- Published
- 2024-09-27
- DOI
- https://doi.org/10.1186/s12916-024-03637-z
- Citations
- 10
- Primary Topic
- Biomedical Ethics and Regulation
- Type
- article
- Field-Weighted Citation Impact
- 3.27
Funders
- National Natural Science Foundation of China