A
- AADA
- Abbreviated Antibiotic Drug Application
- ABPI
- Association of British Pharmaceutical Industries
- ACE
- Adverse Clinical Event
- ACRA
- Associate Commissioner for Regulatory Affairs
- ACRPI
- Association for Clinical Research in the pharmaceutical Industry (UK)
- ACT
- Applied Clinical Trials
- ADE
- Adverse Drug Event, Adverse Drug Effect
- ADR
- Adverse Drug Reaction
- AERS
- Adverse Event Reporting System
- AHA
- Area Health Authority
- AICRC
- Association of Independent Clinical Research Contractors (UK)
- ANDA
- Abbreviated New Drug Application
- API
- Active Pharmaceutical Ingredients
- AQL
- Acceptable Quality Level
- ARENA
- Applied Research Ethics National Association
- ASMF
- Active Substance Master Files
- ASR
- Annual Safety Report
- ASPR
- Anonymised Single Patient Report
- ATSDR
- Agency for Toxic Substance & Disease Registry
- ADME
- Absorption, Distribution, Metabolism and Excretion
B
- BAPP
- British Association of Pharmaceutical Physicians
- BARQA
- British Association of Research Quality Assurance
- BCE
- Beneficial Clinical Event
- BGMA
- The British Generic Manufacturer's Association
- BMA
- British Medical Association
- BIO
- Biotechnology Industry Association
- BP
- British Pharmacopoeia
- BROMI
- Better Regulations of Medicines Initiative
C
- CAs
- Competent Authorities (EU)
- CD
- Controlled Drug
- CEP
- Certificate of European Pharmacopeia (certificate of suitability)
- CAPRA
- Canadian Association of Pharmaceutical Regulatory Affairs
- CBER
- Centre for Biologics Evaluation and Research
- CCDS
- Company Core Data Sheet
- CCSI
- Company Core Safety Information
- CDC
- Centres for Disease Control and Prevention
- CDER
- Centre for Drug Evaluation and Research
- CDRH
- Centre for Devices and Radiological Health
- CFSAN
- Centre for Food Safety and Applied Nutrition
- CIB
- Clinical Investigators Bureau
- CIOMS
- Council for International Organisations of Medical Sciences (WHO)
- CHMP
- Committee for Medicinal Products for Human Use
- CMC
- Chemistry and Manufacturing Controls
- CMS
- Concerned Member State
- CPMP
- Committee for Proprietary Medicinal Products (EMA)
- CSD
- Committee on Safety of Medicines (UK)
- CRA
- Clinical Research Associate
- CRC
- Clinical Research Coordinator
- CRO
- Clinical Research Organisation
- CSA
- Clinical Study Agreement
- CSM
- Committee on Safety of Medicines (UK)
- CSR
- Clinical Study Report
- CTA
- Clinical Trail Application
- CTD
- Common Technical Document
- CTD
- Clinical Trail Directive
- CTC
- Clinical Trial Certificate
- CTX
- Clinical Trial Exemption
- CP
- Centralised Procedure
- CPP
- Certificate of Pharmaceutical Product
- CRO
- Contract Research Organisation
- CTA
- Clinical Trial Application
- CTC
- Clinical Trial Certificate
- CUVP
- The Committee for Veterinary Medicinal Products (EMA)
D
- DB
- Double Blind
- DB
- Device Bulletin
- DCF
- Data Clarification Request Form
- DCP
- Decentralised Procedure
- DHCP
- Dear Healthcare Professional Communication
- DCSI
- Development Core Safety Information
- DSUR
- Development Safety Update Report
- DDPS
- Detailed Description of Pharmacovigilance System
- DESI
- Drug Efficacy Study Implementation
- DHR
- Device History Record
- DIA
- Drug Information Association
- DMC
- Data Monitoring Committee
- DMF
- Drug Master File
- DMR
- Drug Master Record
- DMRC
- Defective Medicines Report Centre
- DRF
- Drug Range Finding (Study)
- DSMB
- Data and Safety Monitoring Board
E
- EAB
- Ethical Advisory Board
- EC
- European Commission
- EC
- European Community
- eCTD
- Electronic Common Technical Document
- EEA
- European Economic Area
- EDQM
- European Directive for the Quality of Medicines and Healthcare
- EFPIA
- European Federation of Pharmaceutical Industry Associations
- EFTA
- European Free Trade Association
- EMA
- European Medicines Agency
- EOP1
- End of Phase1
- EOP2
- End of Phase2
- EPRG
- European Pharmacovigilance Research Group
- EPAR
- European Public Assessment Report
- EP
- European Pharmacopeia
- ESRA
- European Society of Regulatory Affairs
- EUCOMED
- European Confederation of Medical Devices Association
- EQA
- European Quality Award
- EU
- European Union
- EUDRA
- European Union Drug Regulatory Authorities
F
- FDA
- Food and Drug Administration
- FOI
- Freedom of Information
- FOIA
- Freedom of Information Act
G
- GCP
- Good Clinical Practice
- GDP
- Good Distribution Practise
- GHTF
- Global Harmonisation Task Force
- GGP
- Good Guidance Practice
- GLP
- Good Laboratory Practice
- GMDN
- Global Medical Device Nomenclature
- GMO
- Genetically Modified Organisms
- GMP
- Good Manufacturing Practise
- GPvP
- Good Pharmacovigilance Practise
H
- HIMA
- Health Industry Manufacturers Association
- HCP
- Health Care Professional
I
- IB
- Investigational Brochure
- IBD
- International Birth Date
- ICDRA
- International Conference of Drug Regulatory Authorities
- ICH
- International Conference on Harmonisation
- ICSR
- Individual Case Safety Report
- IDE
- Investigational Device Exemption
- IDR
- Idiosyncratic Drug Reaction
- IDBM
- Independent Data Monitoring Board
- IEC
- Independent Ethics Committee
- ILAR
- Institute for Laboratory Animal Research
- IMB
- Irish Medicines Board
- IMP
- Investigational Medicinal Products
- IMPD
- Investigational Medicinal Product Dossier
- IMS
- Information Management Strategy
- IND
- Investigational New Drug (application)
- INDC
- Investigational New Drug Committee
- INN
- International Approved Names for Pharmacopoeial Substances
- IPRO
- Independent Pharmaceutical Research Organisation
- IRD
- International Registration Document
- IRB
- Institutional Review Board
- ISE
- Integrated Summary of Efficacy
- ISO
- International Standards Organization
- ITT
- Intent to Treat
- IVD
- In Vitro Device, In Vitro diagnosis
L
- LOA
- Letter of Agreement
- LOQ
- Limit of Quantification
- LOD
- Limit of Detection
M
- MA
- Marketing Authorisation
- MAA
- Marketing Authorisation Application
- MAD
- Multiple Ascending Dose
- MAH
- Marketing Authorisation Holder (EC)
- MCA
- Medicines Control Agency (UK)
- MDA
- Medical Device Agency (UK)
- MDA
- Medical Device Alert
- MDD
- Medical Device Directive
- MDI
- Metered Dose Inhaler
- MDLO
- Medical Device Liaison Officer
- MEdDRA
- Medical Dictionary for Drug Regulatory Affairs
- ML
- Manufacturers Licence
- MDMA
- Medical Device Manufacturers Association
- MDR
- Medical Device Reporting
- MDR
- Medical Device Regulation
- MDV
- Medical Device Vigilance
- MDD
- Medical Device Directives (EU)
- MLD
- Minimum Lethal Dose
- MPA
- Multiple Project Assurance
- MRA
- Multiple Recognition Agreements
- MRD
- Multiple Rising Dose
- MRP
- Mutual Recognition Procedure
- MTD
- Maximum Tolerated Dose
- MHRA
- Medicines and Healthcare Products Regulatory Agency
N
- NADA
- New Animal Drug Application
- NAS
- New Active Substance
- NBs
- Notified Bodies (EU)
- NCBI
- National Centre for Biotechnology Information
- NCCLS
- National Committee of Clinical laboratory Standards
- NCE
- New Chemical Entity
- NCI
- National Cancer Institute
- NCPIE
- National Council on Patient Information and Education
- NCTR
- National Council for Toxicological Research
- NDA
- New Drug Application
- NDBA
- National Drugs Advisory Board (Ireland)
- NDAC
- Non-prescription Drugs Advisory Committee
- NIAID
- National Institute of Allergies and Infectious Diseases (NIH)
- NIBSC
- National Institute for Biological Standards and Control
- NIH
- National Institutes of Health
- NINDS
- National Institutes of Neurological Disorders and Stroke (NIH)
- NME
- New Molecular Entity
- NMI
- Non Medicinal Ingredients
- NPA
- The National Pharmaceutical Association (UK)
- NRC
- Nuclear Regulatory Commission
- NSAID
- Nonsteroidal Anti-inflammatory Drug
- NTA
- Notice to Applicants
O
- ODD
- Orphan Drug Designation
- OTC
- Over the Counter (drugs)
P
- PAGB
- Proprietary Association of Great Britain
- PD
- Pharmacodynamics
- PAPs
- Product Analysis Prints
- PASS
- Post Authorisation Safety Study
- PCT
- Primary Care Trust
- PDA
- Parenteral Drug Association
- PDP
- Product Development Protocols (for Medical Devices)
- PER
- Pharmaceutical Evalution Reports (EMA)
- PI
- Package Inserts
- PIL
- Patient Information Leaflet
- PIP
- Paediatric Investigation Plan
- PL
- Product Licence
- PK
- Pharmacokinetics
- POM
- Prescription Only Medicine
- PMA
- Pre-Market Approval (Application) (for Medical Devices)
- PMS
- Post Marketing Surveillance
- PRRs
- Proportioned Reporting Ratios
- PSI
- Pharmaceutical Society of Ireland
- PSNI
- Pharmaceutical Society of Northern Ireland
- PSUR
- Periodic Safety Update Report (EMA)
- PUMA
- Paediatric Use Marketing Authorisation
- PV
- Pharmacovigilance
Q
- QA
- Quality Assurance
- QC
- Quality Control
- QOS
- Quality Overall Summary
- QRD
- Quality Review of Documents
- QP
- Qualified Person
- QPPV
- Qualified Person for Pharmacovigilance
- QM
- Quality Management
R
- RAMA
- Remote Access for Marketing Authorisations
- R&D
- Research and Development
- rINN
- recommended International Non-proprietary Name
- RMP
- Risk Management Plan
- RAPS
- Regulatory Affairs Professional Society (USA)
- RPSGB
- Royal Pharmaceutical Society of Great Britain
- RMS
- Reference Member State
- RSI
- Reference Safety Information
- RP
- Responsible Person
S
- SAD
- Single Ascending Dose
- SAE
- Serious Adverse Event
- SAL
- Sterility Assurance Level
- SAMM
- Safety Assessment of Marketed Medicines
- SBA
- Summary Basis of Approval
- SCT
- Society for Clinical Trials
- SME
- Significant Medical Event
- SME
- Subject Matter Expert
- SMF
- Site Master File
- SMQ
- Standardised MedDRA Query
- SMT
- Safety Management Team
- SOCRA
- Society of Clinical Research Associates
- SOC
- System Organ Class
- SOP
- Standard Operating Procedure
- SPC
- Summary of Product Characteristics
- SmPC
- Summary of Product Characteristics
- SQA
- Society of Quality Assurance
- SRD
- Single Rising Dose
- SUD
- Sudden Unexpected Death
- SUSAR
- Suspected, Unexpected, Serious adverse reaction
T
- TK
- Toxicokinetics
- TOPRA
- The Association for Regulatory Affairs Professionals
U
- USAN
- United States Adopted Names
- USP
- United States Pharmacopeia
- USPI
- United States Product Information
- UKPAR
- United Kingdom Public Assessment Report
V
- VAERS
- Vaccine Adverse Event Reporting System
- VAMF
- Vaccine Antigen Master File
W
- WHO
- World Health Organisation
- WI
- Working Instruction
- WP
- Working Practise
