| Term | Description |
| ADCO | Addendum to Clinical Overview |
| ADRs | Adverse Drug Reactions |
| AE | Adverse Event |
| AERS | Adverse Event Reporting System |
| ANDA | Abbreviated New Drug Application |
| ATC | Anatomical
Therapeutic Chemical (in Anatomical
Therapeutic Chemical Classification System) |
| ATMP | Advanced Therapy Medicinal Product |
| CAPA | Corrective And Preventive Action |
| CCDS | Company Core Data Sheet |
| CCSI | Company Core Safety Information |
| CHMP | Committee for Medicinal Products for Human Use |
| CIOMS | Council for International Organizations of Medical Sciences |
| CMDh | Coordination
Group for Mutual Recognition and Decentralised Procedures - Human |
| CMS | Concerned Member State |
| CRO | Contract Research Organization |
| CT | Clinical Trial |
| CTD | Common Technical Document |
| DCP | Decentralised Procedure |
| DDD | Defined Daily Dose |
| DHPC | Direct healthcare professional communication |
| DIBD | Development international birth date |
| DLP | Data Lock Point |
| DME | Designated Medical Event |
| DSUR | Development safety update report |
| DUS | Drug Utilization Study |
| EMA | European Medicine Agency |
| EU | European Union |
| EURD | European Union Reference Date |
| EV | Eudravigilance |
| FDA | Food and Drug Administration |
| GCP | Good Clinical Practice |
| GMP | Good Manufacturing Practice |
| GVP | Good Pharmacovigilance Practice |
| IB | Investigator´s Brochure |
| IBD | International birth date |
| ICH | International Council for Harmonisation
of Technical Requirements for Pharmaceuticals for Human Use |
| ICSRs | Individual Case Safety Reports |
| IME | Important Medical Event |
| IND | Investigational New Drug |
| INN | International Non-proprietary Name |
| LBI | Late Breaking Information |
| MA | Marketing Authorisation |
| MAH | Marketing Authorisation Holder |
| MedDRA | Medical Dictionary for Regulatory Activities |
| MHRA | Medicines and Healthcare Products Regulatory Agency |
| MRP | Mutual Recognition Procedure |
| NAP | National Authorised Product |
| NCA | National Competent Authority |
| NDA | New Drug Application |
| PASS | Post-authorisation safety study |
| PBRER | Periodic Benefit-Risk Evaluation Report |
| PI | Product Information |
| PIL | Product Information Leaflet |
| PL | Package Leaflet |
| PRAC | Pharmacovigilance Risk Assessment Committee |
| PSMF | Pharmacovigilance system master file |
| PSUR | Periodic Safety Update Report |
| PSUSA | Periodic Safety Update Single Assessment |
| PT | Preferred Term |
| PTD | Patient Treatment Days |
| PTY | Patient Treatment Years |
| PV | Pharmacovigilance |
| QPPV | Qulified Person responsible for Pharmacovigilance |
| REMS | Risk Evaluation & Mitigation Strategies |
| RMM | Risk Minimisation Measure |
| RMP | Risk Management Plan |
| RMS | Reference Member State |
| RSI | Referenced Safety Information |
| SAE | Serious Adverse Event |
| SAR | Serious Adverse Reaction |
| SDEA | Safety Data Exchange Agreement |
| SmPC | Summary of Product Characteristics |
| SMQ | Standardized MedDRA Query |
| SOC | System Organ Class |
| SOP | Standard Operating Procedure |
| TSSS | Tabular Summary of Safety Signals |
| WHO | World Health Organization |
| XEVIMPD | Extended EudraVigilance Investigational Medicinal Product Dictionary |
| XEVPRM | eXtended EudraVvigilance Product Report Message |