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The guidelines of PMS for CGTPs in China
| Guideline | Main content | |
|---|---|---|
| 1 | Technical guidelines for long-term follow-up clinical studies of gene therapy products [116] | Long term follow-up |
| 2 | Technical guidelines for clinical risk management plan of chimeric antigen receptor T cell (CAR-T) therapeutic products [117] | Risk management |
| 3 | Guidance for writing a clinical risk management plan (for Trial Implementation) [118] | Risk management |
| 4 | Guideline for pharmacovigilance examination [119] | PV |
