Glossary
Medical Market Consultants
Managing the Business of Science™
Experience. Service. Quality.
Commonly Used Life Sciences Industry Acronyms
To help our clients and readers navigate the many acronyms used in the life science industry we trust that the following guide will be helpful. While not exhaustive it covers commonly used terms by regulatory personnel and other stakeholders with a predominant focus on terms used by Health Canada.
APQR
AR
ASQ
ATI
BC
BGTD
BHP
BP
CADTH
CDI
CDR
CDSA
CEDAC
CEPA
CF
CFIA
CIOM
CMC
CMDCAS
CN
COA
COM
CPID
CPP
CPS
CQA
CRP
CSA
CS-BE
CTA
CTA-A
CTD
DIN
DIN-A
DIN-B
DIN-D
DIN-F
DMF
DNF
DPD
DQAC
DQTC
DSL
eCTD
EL
EMA
F&DA
FDA
FDR
GCP
GLP
GMP
HC
HPB
HPFB
HPFBI
IB
ICH
INCI
INDS
IRN
ISO
ITA
IVDD
JP
MA
MD
MDB
MDEL
MDR
MHPD
MI
MPR
MSDS
NAPRA
NDA
NC
NCC
NDS
NDSAC
NF
NHP
NHPD
NHPR
NMI
NOC
NOC/c
NOD
NOL
NON-WD
NPN
NSN
NSNR
OCS
OTC
PAAB
Ph. Eur
PIC/s
PLA
PM
PMPRB
PMRA
PSUR
QA
QAP
QAR
QC
QIS-B
QIS-P
QMS
QOS-CE
QOS
QOS-BS
QPIC
QSIT
QSR
RA
RAC
RAC-CAN
REB
Rx
SAND
SAP
SAR
SCC
SI
SIPD
SL
SNDS
SOP
SRF
TPD
USP
VDD
vNHP
WHO
Annual Product Quality Review
Adverse Reaction
American Society for Quality
Access to Information
Batch Certificate
Biologics and Genetic Therapies Directorate
British Herbal Pharmacopeia
British Pharmacopeia
Canadian Agency for Drugs and Technologies in Health
Comparative Drug Index
Common Drug Review
Controlled Drugs and Substances Act
Canadian Expert Drug Advisory Committee
Canadian Environmental Protection Act
Canadian Formulary
Canadian Food Inspection Agency
Council for International Organizations of Medical Sciences
Chemistry, Manufacturing and Controls
Canadian Medical Device Conformity Assessment System
Cosmetic Notification
Certificate of Analysis
Certificate of Manufacture
Certified Product Information Document
Certificate of Pharmaceutical Product
Compendium of Pharmaceuticals and Specialties
Certified Quality Auditor
Canadian Reference Product
Canadian Standards Association
Bioequivalence Comprehensive Summaries
Clinical Trial Application
Clinical Trial Application Amendment
Common Technical Document
Drug Identification Number
Drug Identification Number
Drug Identification Number Biologics
Drug Identification Number Disinfectants
Drug Identification Number (Category IV)
Drug Master File
Drug Notification Form
Drug Product Database
Drug Quality Assessment Committee
Drug Quality and Therapeutics Committee
Domestic Substances List
Electronic Common Technical Document
Establishment Licence
European Medicines Agency
Food and Drugs Act
US Food and Drug Administration
Food and Drug Regulations
Good Clinical Practices
Good Laboratory Practices
Good Manufacturing Practices
Health Canada
Health Protection Branch
Health Products and Food Branch
Health Products and Food Branch Inspectorate
Investigator’s Brochure
International Conference on Harmonisation
International Nomenclature of Cosmetic Ingredients
Investigational New Drug Submission
Information Requests Notification
International Organization for Standardization
Investigational Testing Application
In Vitro Diagnostic Device
Japanese Pharmacopeia
Market Access
Medical Device
Medical Devices Bureau
Medical Device Establishment Licence
Medical Device Regulations
Marketed Health Products Directorate
Medicinal Ingredient
Mandatory Problem Report
Material Safety Data Sheet
National Association of Pharmaceutical Regulatory Affairs
U.S. New Drug Application
Notifiable Change
National Coordination Centre
New Drug Submission
National Drug Scheduling Advisory Committee
National Formulary
Natural Health Product
Natural Health Products Directorate
Natural Health Product Regulations
Non-Medicinal Ingredient
Notice of Compliance
Notice of Compliance with Conditions
Notice of Deficiency
No Objection Letter
Notice of Noncompliance – Withdrawal
Natural Product Number
Not Satisfactory Notice
New Substances Notification Regulations
Office of Controlled Substances
Over-the-Counter
Pharmaceutical Advertising Advisory Board
European Pharmacopeia
Pharmaceutical Inspection Cooperation Scheme
Product Licence Application
Product Monograph
Patented Medicines Prices Review Board
Pest Management Regulatory Agency
Product Safety Update Report
Quality Assurance
Quality Assurance Person
Quality Assurance Report
Quality Control
Quality Information Summary – Biologics
Quality Information Summary – Pharmaceuticals
Quality Management System
Quality Overall Summary – Chemical Entity
Quality Overall Summary
Quality Overall Summary – Bioequivalence Study
Qualified Person in Charge
Quality System Inspection Technique
Quality System Regulations
Regulatory Affairs
Regulatory Affairs Certification
Regulatory Affairs Certification (Canada)
Research Ethics Board
Prescription
Supplemental Abbreviated New Drug Submission
Special Access Program
Special Access Request
Standards Council of Canada
Self-Inspection
Submission Information Policy Division
Site Licence
Supplemental New Drug Submission
Standard Operating Procedure
Site Reference Files
Therapeutic Products Directorate
United States Pharmacopeia
Veterinary Drugs Directorate
Veterinary Natural Health Product
World Health Organization
