Regulatory Affairs Industry Acronyms and Abbreviations
| 510K AA ABC APQR APRC AR ASQ ATI BC BGTD BHP BP CADTH CBA CCT CDI CDR CDR CDSA CEDAC CEPA CF CFIA CHA CIOMS CMC CMDCAS CN COA COM CPID CPP CPS CQA CRP CSA CTA CTA-A CTD DIN DIN-A DIN-B DIN-D DIN-F DL DMF DNF DPD DQAC DQTC DSL ECC eCTD EL F&DA FDA FDDR FMEA GA GC GCP GLP GMP HAACP HC HECS HPB HPFB HPFBI HPLC IB IQ ICH INCI INDS ISO ITA IVDD JP LCA MA MD MDB MDEL MDR MDSTC MHPD MI MPR MSDS NAPRA NBPDF NBPSC NC NCC NDS NDSAC NF NHP NHPD NHPR NIDPF NMI NOC NOC/c NOD NOL NON-WD NPN NSN NSNR OCS ODBF y OQ OTC PAAB PFMEA Ph. Eur. PIC/s PLA PM PMPRB PMRA PQ PSUR QA QAP QAR QC QIS-B QIS-P QMS QOS–CE QOS QOS-BS QPIC QSIT QSR RA RAC RACCAN RAMQ RDP REB Rx SANDS SAP SAR SCC SI SIPD SL SNDS SOP SRF SSOP TPD USP VDD vNHP WHO |
Premarket Notification (US) Atomic Absorption Alberta Blue Cross Annual Product Quality Review Atlantic Pharmacare Review Committee 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 Certified Biomedical Auditor Certified Calibration Technician Comparative Drug Index Common Drug Review Common Drug Review Controlled Drugs and Substances Act Canadian Expert Drug Advisory Committee Canadian Environmental Protection Act Canadian Formulary Canadian Food Inspection Agency Certified HACCP Auditor Council for International Organizations of Medical Sciences Chemistry, Manufacturing and Controls Canadian Medical Device Conformity Assessment System Cosmetic Notification Certificate of Analysis Certificate of Manufacturer Certified Product Information Document Certificate of Pharmaceutical Product Compendium of Pharmaceuticals and Specialties Certified Quality Auditor Canadian Reference Product Canadian Standards Association 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) Dealer’s License (Dealer’s Licence) Drug Master File Drug Notification Form Drug Product Database Drug Quality Assessment Committee Drug Quality and Therapeutics Committee Domestic Substances List Economic Council of Canada Electronic Common Technical Document Establishment License (Establishment Licence) Food and Drugs Act US Food and Drug Administration Food and Drug Regulations Failure Mode and Effect Analysis Gap Analysis Gas Chromatography Good Clinical Practices Good Laboratory Practices Good Manufacturing Practices Hazard Analysis and Critical Control Points Health Canada Healthy Environments and Consumer Safety Health Protection Branch Health Products and Food Branch Health Products and Food Branch Inspectorate High Performance Liquid Chromatography Investigator’s Brochure Installation Qualification International Conference on Harmonisation International Nomenclature of Cosmetic Ingredients Investigational New Drug Submission International Organization for Standardization Investigational Testing Application In Vitro Diagnostic Device Japanese Pharmacopeia Low Cost Alternative Market Access Medical Device Medical Devices Bureau Medical Device Establishment Licence Medical Device Regulations Manitoba Drug Standards and Therapeutic Committee Marketed Health Products Directorate Medicinal Ingredient Mandatory Problem Report Material Safety Data Sheet National Association of Pharmaceutical Regulatory Affairs New Brunswick Prescription Drug Program Formulary New Brunswick Product Selection Committee 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 Newfoundland and Labrador Interchangeable Drug Products Formulary Non-Medicinal Ingredient Notice of Compliance Notice of Compliance with Conditions Notice of Deficiency No Object Letter Notice of Noncompliance – Withdrawn Natural Product Number Not Satisfactory Notice New Substances Notification Regulations Office of Controlled Substances Ontario Drug Benefit Formulary Operational Qualification Over the Counter Pharmaceutical Advertising Advisory Board Process Failure Mode and Effect Analysis European Pharmacopeia Pharmaceutical Inspection Cooperation Scheme Product Licence Application Product Monograph Patented Medicines Prices Review Board Pest Management Regulatory Agency Performance Qualification 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) La Régie de l’assurance maladie Reference Drug Program 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 Standard Sanitation Operating Procedures Therapeutic Products Directorate United States Pharmacopeia Veterinary Drugs Directorate Veterinary Natural Health Product World Health Organization |
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