| A | |
| ADE | Adverse Drug Experience (US) |
| ADR | Adverse Drug Reaction |
| AE | Adverse Event (EU), Adverse Experience (US) |
| AR | Assessment Report |
| ASMF | Active Substance Master File |
| ASR | Annual Safety Report |
| ATC-Code | Anatomical Therapeutic Chemical-Code (WHO) |
| ATMP | Advanced Therapy Medicinal Product |
| B | |
| BE | Bioequivalence |
| C | |
| (C)CDS | (Company) Core Data Sheet |
| CA | Competent Authority |
| CAPA | Corrective and Preventive Action |
| CBER | Center for Biologics Evaluation and Research Committee for the evaluation of biologic products at the FDA |
| CCSI | Company Core Safety Information |
| CDA | Confidential Disclosure Agreement |
| CDER | Center for Drug Evaluation and Research |
| CFR | Code of Federal Regulations (US) |
| CHMP | Committee for Medicinal Products for Human Use |
| CIOMS | Council for International Organization of Medical Sciences |
| CMD(h) | Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human |
| CMS | Concerned Member State |
| CTD | Common Technical Document or Clinical Trial Document or Clinical Trials Directive (officially Directive 2001/20/EC) |
| CTDMB | Clinical Trial Data Monitoring Board |
| D | |
| DCP | Decentralised Procedure |
| DCSI | Development Core Safety Information |
| DLP | Data Lock Point |
| DMC | Data Monitoring Committee |
| DSMB | Data Safety Monitoring Board |
| E | |
| EBD | European Birthdate |
| EC | European Commission or Ethics Committee |
| E | |
| eCTD | electronic Common Technical Document |
| E | |
| EEA | European Economic Area |
| EEA | European Economic Area |
| EMA | European Medicines Agency |
| EPAR | European Public Assessment Report |
| EU | European Union |
| EudraCT | European Clinical Trials Database |
| EV | EudraVigilance |
| EVCT | Eudravigilance Clinical Trial Module |
| EVMPD | EudraVigilance Medicinal Product Dictionary |
| EVPM | Eudravigilance Post-Authorisation Module |
| EVPRM | EudraVigilance Product Report Message |
| F | |
| FDA | Food and Drug Administration (US) |
| FU(P) | Follow up |
| G | |
| GCP | Good Clinical Practice |
| GL | Guideline |
| GMP | Good Manufacturing Practice |
| GVP | Guideline on Good Pharmacovigilance Practices |
| H | |
| HA | Health Authority |
| HBD | Harmonised Birth Date |
| HMA | Heads of Medicines Agencies |
| HP | Healthcare Professional |
| I | |
| IB | Investigator’s Brochure |
| IBD | International Birthdate |
| IC | Informed Consent |
| ICD | Informed Consent Document or International Code of Diseases |
| ICF | Informed Consent Form |
| ICH | International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use |
| ICH | International Conference on Harmonization |
| ICSR | Individual Case Safety Report |
| IDMB | Independent Data Monitoring Board |
| IMP | Investigational Medicinal Product |
| IND | Investigational New Drug |
| IT | Information Technology |
| L | |
| LLT | Low Level Term |
| LoQ | List of Questions |
| M | |
| M & S | Marketing & Sales |
| MA | Marketing Authorisation |
| MAA | Marketing Authorisation Applicant |
| MAH | Marketing Authorisation Holder |
| MedDRA | Medical Dictionary for Regulatory Activities |
| MFR | Manufacturer |
| MHRA | Medicines and Healthcare products Regulatory Agency (UK) |
| MLM | Medical Literature Monitoring |
| MP | Medicinal Product |
| MRP | Mutual Recognition Procedure |
| MS | Member State |
| MSSO | Maintenance and Support Services Organization (MedDRA) |
| N | |
| N/A | Not applicable |
| NCA | National Competent Authority |
| NDA | New Drug Approval or New Drug Application |
| NS | Non-serious |
| NtA | Notice to Applicants |
| O | |
| OMP | Orphan Medicinal Product |
| OTC | Over-the-counter (non-prescription medicines) |
| P | |
| PA(D)ER | Periodic Adverse (Drug) Experience Report |
| PAES | Post Authorisation Efficacy Study |
| PASS | Post Authorisation Safety Study |
| PBRER | Periodic Benefit-Risk Evaluation Report |
| PhV | Pharmacovigilance |
| PI | Package Insert or Product Information or Principle Investigator or Parallel Import |
| PIP | Paediatric Investigation Plan |
| PK | Pharmacokinetics |
| PL | Package Leaflet |
| PQR | Product Quality Review |
| PRAC | Pharmacovigilance Risk Assessment Committee |
| PSMF | Pharmacovigilance System Master File |
| PSUR | Periodic Safety Update Report |
| PSUSA | PSUR Single Assessment |
| PT | Preferred Term |
| PUMA | Paediatric Use Marketing Authorisation |
| PV | Pharmacovigilance |
| PVA | Pharmacovigilance Agreement |
| Q | |
| QA | Quality Assurance |
| QA | Quality Assurance |
| QC | Quality Check |
| QC | Quality Check or Quality Control |
| QM | Quality Management |
| QP (GMP) | Qualified Person (Good Manufacturing Practice) |
| QPPV | Qualified Person responsible for Pharmacovigilance |
| QRD | Quality Review of Documents |
| R | |
| R & D | Research & Development |
| RA | Regulatory Affairs or Regulatory Authority |
| RAS | Rapid Alert System |
| REG | Regulation |
| RMP | Risk Management Plan |
| RMS | Reference Member State |
| RSI | Reference Safety Information |
| S | |
| SA | Scientific Advice |
| SADR | Serious Adverse Drug Reaction |
| SAE | Serious Adverse Event |
| SC | Study Coordinator |
| SD | Source Data / Source Document or Single Dose or Standard Deviation |
| SDEA | Safety Data Exchange Agreement |
| SDS | Signal Detection Spreadsheet |
| SEQ | Safety, Efficacy, Quality |
| SESAR | Suspected Expected Serious Adverse Reaction |
| SME | Significant Medical Event or Small and Medium Enterprises |
| SMF | Site Master File |
| SmPC | Summary of Product Characteristics |
| SMQ | Standardised MedDRA Queries |
| SOP | Standard Operating Procedure |
| SPC | Supplementary Protection Certificate |
| SRC | Safety Review Committee |
| SUSAR | Suspected Unexpected Serious Adverse Reaction |
| T | |
| TPM | Third Party Manufacturer |
| V | |
| VAERS | Vaccine Adverse Event Reporting System |
| VeDDRA | Veterinary Dictionary for Drug Related Affairs |
| VMP | Veterinary Medicinal Product |
| W | |
| WHO | World Health Organisation |
| WP | Working Procedure |
| X | |
| XEVMPD | eXtended Eudravigilance Medicinal Product Dictionary |
| XML | Extensible Markup Language |
