Table 2.
Regulation of cell-based therapeutic products in the United States, the European Union (and the United Kingdom), and Japan
| US | EU (and UK) | Japan | |
|---|---|---|---|
| Classification of PSC-derived CTPs | 351 HCT/P | Advanced Therapy Medicinal Product (ATMP) | Cell-Processed Product |
| Product type | Biologics or Medical Devices | Medicinal Products | Regenerative Medical Products |
| Regulatory authority | FDA | EMA (MHRA in UK) | MHLW and PMDA |
| Compliance with GCP in clinical trials | essential | essential | essential in commercial clinical trials |
| Good Practice(s) for Quality and Manufacturing Controls | cGMP (for biologics) or QSR (for medical devices) | GMP for ATMPs | GCTP |
| Conditional Marketing Authorization with Putative Efficacy | RMAT/HDE | Hospital Exemption (Article 28 of Regulation 1394/2007/EC) | Conditional and Term-limited Approval |
| Use of unlicensed products | Federal regulations prohibit manufacturers from introducing unapproved 351 HCT/Ps into interstate commerce. | Specials (Article 5 (1) of Directive 2001/83/EC) | Specified Processed Cells under the RM Safety Act |