Glossary of common terms used in pharmaceutical and biotechnology industry
ADME – Absorption, Distribution, Metabolism, Excretion
API – Active Pharmaceutical Ingredient
AQL – Acceptable Quality Level
BLA – Biologics License Application
BMR – Batch Manufacturing Record
BPD – Breakthrough Therapy Designation
CAPA – Corrective and Preventive Action
CBER – Center for Biologics Evaluation and Research
CDMO – Contract Development and Manufacturing Organization
CDRH – Center for Devices and Radiological Health
CER – Comparative Effectiveness Research
CFR – Code of Federal Regulations
CMC – Chemistry, Manufacturing and Controls
CMO – Contract Manufacturing Organization
CMS – Centers for Medicare and Medicaid Services
CPT – Current Procedural Terminology
CRF – Case Report Form
CRISPR – Clustered Regularly Interspaced Short Palindromic Repeats
CRO – Contract Research Organization
CT – Clinical Trial
CTMS – Clinical Trial Management System
DMC – Data Monitoring Committee
DoE – Design of Experiments
DQ – Design Qualification
DRG – Diagnosis-Related Group
EBM – Evidence-Based Medicine
EDC – Electronic Data Capture
FDC – Fixed-Dose Combination
FMEA – Failure Modes and Effects Analysis
GCP – Good Clinical Practice
GLP – Good Laboratory Practice
GMP – Good Manufacturing Practice
GPO – Group Purchasing Organization
GTN – Gross-to-net adjustments
HCP – Healthcare Professional
HCPCS – Healthcare Common Procedure Coding System
HEOR – Health Economics and Outcomes Research
HPLC – High-Performance Liquid Chromatography
HTA – Health Technology Assessment
HVAC – Heating, Ventilation, and Air Conditioning
ICD – International Classification of Diseases
ICF – Informed Consent Form
ICH – International Council for Harmonisation
IND – Investigational New Drug
IP – Intellectual Property
IQ – Installation Qualification
IRA – Inflation Reduction Act
IRB – Institutional Review Board
ITT – Intention-To-Treat
IVR – Interactive Voice Response
KOL – Key Opinion Leader
LC-MS – Liquid Chromatography-Mass Spectrometry
LPLV – Last Patient Last Visit
MAb – Monoclonal Antibody
MAC – Maximum Allowable Cost
MCO – Managed Care Organization
MSL – Medical Science Liaison
NADAC – National Average Drug Acquisition Cost
NCE – New Chemical Entity
NDA – New Drug Application
NDC – National Drug Code
NPI – National Provider Identifier
OBA – Outcomes-Based Agreements
QQ – Operational Qualification
OOS – Out of Specification
Payers
PAT – Process Analytical Technology
PBM – Pharmacy Benefit Manager
PBO – Placebo
PD-1 – Programmed Death-1
PDP – Prescription Drug Plan
PDUFA – Prescription Drug User Fee Act
PEG – Polyethylene Glycol.
PEGylated – Polyethylene Glycol Coated
PFS – Progression-Free Survival
PI – Principal Investigator
PK – Pharmacokinetics
PK/PD – Pharmacokinetics/Pharmacodynamics
POC – Point of Care
PPQ – Process Performance Qualification
PRP – Platelet-Rich Plasma
QALY – Quality-Adjusted Life Year
QBD – Quality by Design
QC – Quality Control
QoL – Quality of Life
QP – Qualified Person
R&D – Research and Development
RNA – Ribonucleic Acid
RNAi – RNA Interference
SAE – Serious Adverse Event
sBLA – Supplemental Biologics License Application
SMO – Site Management Organization
SMR – Source Medical Record
SOP – Standard Operating Procedure
TDM – Therapeutic Drug Monitoring
TGA – Therapeutic Goods Administration
TPP – Target Product Profile
URS – User Requirement Specification
USAN – United States Adopted Name
USP – United States Pharmacopeia
VEGF – Vascular Endothelial Growth Factor
VIP – Very Important Person (in clinical trial context)
VMP – Validation Master Plan
VTE – Venous Thromboembolism
WAC – Wholesale Acquisition Cost.
WHO – World Health Organization
Regulatory authorities involved in the regulating pharmaceutical drug manufacturing
FDA – Food and Drug Administration (US)
AEMPS – Spanish Agency of Medicines and Medical Devices
ANMAT – Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (Argentina)
ANVISA – Agência Nacional de Vigilância Sanitária (Brazil)
APVMA – Australian Pesticides and Veterinary Medicines Authority
BfArM – Bundesinstitut für Arzneimittel und Medizinprodukte (Germany)
CBER – Center for Biologics Evaluation and Research (FDA)
CDER – Center for Drug Evaluation and Research (FDA)
EAEU – Eurasian Economic Union
EMA – European Medicines Agency
EMEA – European Medicines Evaluation Agency (former name of EMA)
FDA/CDRH – Center for Devices and Radiological Health (FDA)
FIMEA – Finnish Medicines Agency
G-BA – Gemeinsamer Bundesausschuss (Joint Federal Committee)
HAS – Haute Autorité de Santé (France)
Health Canada – Health Canada
HFEA – Human Fertilisation and Embryology Authority (UK)
HPFB – Health Products and Food Branch (Canada)
HPRA – Health Products Regulatory Authority (Ireland)
HSA – Health Sciences Authority (Singapore)
INFARMED – National Authority of Medicines and Health Products (Portugal)
KFDA – Korea Food and Drug Administration
MCC – Medicines Control Council (South Africa)
MEB – Medicines Evaluation Board (Netherlands)
MHLW – Ministry of Health, Labour and Welfare (Japan)
MHRA – Medicines and Healthcare products Regulatory Agency (UK)
MPA – Medical Products Agency (Sweden)
NAFDAC – National Agency for Food and Drug Administration and Control (Nigeria)
NICE – National Institute for Health and Care Excellence (UK)
NMPA – National Medical Products Administration (China)
PIC/S – Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme.
PMDA – Pharmaceuticals and Medical Devices Agency (Japan)
SFDA – Saudi Food and Drug Authority
SFDA – State Food and Drug Administration (China)
Swissmedic – Swiss Agency for Therapeutic Products
TFDA – Taiwan Food and Drug Administration
TGA – Therapeutic Goods Administration (Australia)
TPD – Therapeutic Products Directorate (Canada)
Pharmaceutical societies and associations
AMA – American Medical Association
AAPS – American Association of Pharmaceutical Scientists
FIP – International Pharmaceutical Federation
PhRMA – Pharmaceutical Research and Manufacturers of America
EFPIA – European Federation of Pharmaceutical Industries and Associations
ISPE – International Society for Pharmaceutical Engineering
PSA – Pharmaceutical Society of Australia
IPA – Indian Pharmaceutical Association
PSJ – Pharmaceutical Society of Japan
PSN – Pharmaceutical Society of Nigeria
PSSA – Pharmaceutical Society of South Africa
RPS – Royal Pharmaceutical Society (UK)
CPhA – Canadian Pharmacists Association
PAI – Pharmaceutical Association of Israel
PSS – Pharmaceutical Society of Singapore
PAT – Pharmaceutical Association of Thailand
APhA – American Pharmacists Association
NCPA – National Community Pharmacists Association
ABIFINA – Brazilian Association of Pharmaceutical Industries
KPA – Korean Pharmaceutical Association
PSNZ – Pharmaceutical Society of New Zealand