| ADR | Adverse Drug Reaction |
| AMA | African Medicines Agency |
| BLA | Biologics License Application |
| CHMP | Committee for Medicinal Products for Human Use |
| CIRS | Center for Innovation in Regulatory Science |
| EUL | Emergency Use Listing |
| HCT/Ps | Cellular and Tissue-Based Products |
| CFR | Code of Federal Regulations |
| IND | Investigational New Drug |
| DCGI | Drugs Controller General of India |
| GMP | Good Manufacturing Practice |
| NDA | New Drug Application |
| PV | Pharmacovigilance |
| RA | Regulatory Affairs |
| REMS | Risk Evaluation and Mitigation Strategy |
| RMP | Risk Management Plan |
| RMAT | Regenerative Medicine Advanced Therapy |
| RWE | Real-World Evidence |
| WHO | World Health Organization |