Table 2 Regulations on each step of developmental process

Classification

Categorization

Advanced Therapy Medicinal Product (ATMP)

Advanced Regenerative Medicine

Regenerative Medical Products

Human cells, tissues, and cellular and tissue-based product (HCT/P)

Procedure

Required to apply for classification with the EMA

N/A

N/A

Required to register with the FDA

Manufacturing License

Required before manufacturing investigational and marketable products

Required before manufacturing marketable products

Not Required for investigational products

Required before manufacturing investigational and marketable products

Not Required; but must submit "Chemistry, Manufacturing, and Control (CMC) " information

Clinical Trial Approval

Prior Authorization

Prior Notification

Market Authorization

Special mentoring

PRIME program

N/A

N/A

N/A

Fast Track program

Priority review

150 Days

N/A

60 days

N/A

6 months

Provisional authorization

Conditional Marketing Authorization (CMA)

Temporary Authorization

Conditional Approval

Conditional and Time-limited Approval

Accelerated Approval

Clinical trials not required

Phase II Clinical Trials Required

Clinical trials not required