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Regulator Performance Framework: Self-assessment Report, July 2018 to June 2019

20 December 2019

Book pagination

Glossary

Acronym Description
AAT Administrative Appeals Tribunal
ACSS Australia-Canada-Singapore-Switzerland Consortium
AEFI Adverse Events Following Immunisation
AEMS Adverse Event Management System
ANVISA National Health Surveillance Agency Brazil
ARCBS Australian Red Cross Blood Service
ARGATG Australian Regulatory Guidelines for Advertising Therapeutic Goods
ARTG Australian Register of Therapeutic Goods
AusPARs Australian Public Assessment Reports
CMI Consumer Medicine Information
CORs Comparable Overseas Regulators
eCTD electronic Common Technical Documents
EDI Electronic Data Interchange
EMA European Medicines Agency
EOI Extension of Indications
GMP Good Manufacturing Practice
HTML Hypertext Markup Language
IMDRF International Medical Device Regulators Forum
IVDs In Vitro Diagnostic Devices
KPIs Key Performance Indicators
NCE New Chemical Entity
NeeS Non eCTD electronic Submissions
NCCIWG Nationally Coordinated Codeine Implementation Working Group
MDSAP Medical Devices Single Audit Program
MMDR Review of Medicines and Medical Device Regulation
OBPR Office of Best Practice Regulation
ODC Office of Drug Control
PDF Portable Document Format
PI Product Information
PIC/S Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
PLAC Prostheses List Advisory Committee
PVIP Pharmacovigilance Inspection Program
RAWG Regulatory Affairs Working Group
RCRC Regulatory Compliance and Risk Committee
RegTech Regulatory and Technical Consultative Forum
RIS Regulation Impact Statement
SARA System for Australian Recall Actions
SAS Special Access Scheme
SLA Service Level Agreement
SMEs Small to Medium Enterprises
TGA Therapeutic Goods Administration
TGACC Therapeutic Goods Advertising Consultative Committee
TGO Therapeutic Goods Order
TIF TGA Industry Forum
TIWGG TGA-Industry Working Group on GMP
USFDA United States Food and Drug Administration

Book pagination