Temporary Disabled. :) please Go back Links to international agencies & organisations | Therapeutic Goods Administration (TGA) www.fgks.org » Address: [go: up one dir, main page] Include Form Remove Scripts Accept Cookies Show Images Show Referer Rotate13 Base64 Strip Meta Strip Title Session Cookies Please try our new Beta ARTG search tool. We've released a trial (beta) version of a new ARTG search tool Please try it and provide feedback. Contact TGA: info@tga.gov.au | 1800 020 653 | More contact info Translate | Subscribe Therapeutic Goods Administration (TGA) Australian Government Department of Health Main menu Home Safety informationReport a problem or side effectReporting adverse events involving medicines, vaccines or medical devices Report an issue with packaging or storage of a medicine AEMS guidance for health professionals AEMS guidance for sponsors Help us promote adverse event reporting: promotional resources kit AlertsCurrent year alerts All alerts RecallsAbout Australian recall actions Recall actions database Uniform recall procedure Prescription opioids Medicine shortages Early warning systemMonitoring communications About the Early Warning System Early Warning System: consumer questions and answers Early Warning System: health professional questions and answers Black Triangle SchemeBlack Triangle Scheme: Information for sponsors Safety information & educationMedicines safety Medical devices safety Database of Adverse Event Notifications (DAEN) COVID-19 COVID-19 vaccinesCOVID-19 vaccine approval process COVID-19 vaccines undergoing evaluation Provisional registrations COVID-19 vaccine safety monitoring and reporting News and updates COVID-19 vaccine advertising and import compliance Information for consumers and health professionals Information for sponsors (industry) International collaboration International COVID-19 vaccines recognised by Australia COVID-19 treatmentsCOVID-19 treatment: Celltrion Healthcare Australia Pty Ltd, regdanvimab (REGKIRONA) COVID-19 treatment: Roche Products Pty Ltd, tocilizumab (ACTEMRA) COVID-19 treatments: Provisional determinations COVID-19 treatments: Provisional registrations COVID-19 treatments: Treatments undergoing evaluation COVID-19 treatments: Advertising compliance COVID-19 treatments: Information for consumers and health professionals COVID-19 treatments: Information for sponsors (industry) COVID-19 testsHow testing works for COVID-19 COVID-19 point-of-care tests COVID-19 rapid antigen self-tests COVID-19 rapid antigen tests - information for manufacturers and sponsors COVID-19 testing in Australia - information for health professionals Advertising COVID-19 rapid antigen point-of-care tests and self-tests (home use tests) Post market review of COVID-19 point-of-care tests ConsumersReport a problem or side effectReporting adverse events involving medicines, vaccines or medical devices Travelling with medicines and medical devicesLeaving Australia Entering Australia Helpful links for travellers Buying medicines and medical devices onlineCounterfeit medicines and devices Can I import it?Personal importation scheme Medicinal cannabis: importation and the traveller's exemption MedicinesHow we regulate medicines Prescription medicines Complementary medicines Over-the-counter (OTC) medicines Vaccines What's on my medicine label? Accessing medicines during a medicines shortage What ingredients are in my medicine? Medical devicesMedical devices overview Transvaginal (urogynaecological) surgical mesh hub Breast implant hub Cosmetic injections Medical device cyber security Advertising hub Consumer information & educationSafety information for consumers Medicines & medical devices Community Q&A MedSearch | Medicine information search app Other web resources for consumers Medicinal cannabis products Health professionalsReport a problem or side effectReporting adverse events involving medicines, vaccines or medical devices Accessing unapproved productsSpecial access scheme Authorised prescribers Clinical trials Personal importation scheme Medicine shortages: Information for Health Professionals Accessing medicines during a medicine shortage Medicinal cannabis Nicotine vaping products Advertising MedicinesLabelling changes: information for health professionals Registration of medicines for the medical termination of early pregnancy Product Information Prescribing medicines in pregnancy database Medicine Shortages Information Initiative Fast track approval pathways for prescription medicines Medical devicesBreast implant associated-anaplastic large cell lymphoma (BIA-ALCL) Breast implant hub Changes to labelling and regulation of hard surface disinfectants (commencing 1 April 2019) Information for medical practitioners on pending up-classification of surgical mesh devices Patient information material for implantable medical devices Importing & supplying medical devices Advice about medical devices for health professionals BiologicalsRegulation of stem cell treatments: information for practitioners Safety informationMedicines Safety Update Medical Devices Safety Update Australian Adverse Drug Reactions Bulletin Medical device incident reporting & investigation scheme (IRIS) articles Implanting medical devices Other resources Health professional information & educationHealth professional educational materials IndustrySME AssistRegulation essentials Workshops and events Podcasts SME guidance material Educational videos Interactive decision tools Case studies Useful resources for business Understanding ingredient requirements Regulation basicsHow therapeutic goods are regulated in Australia Australian Register of Therapeutic Goods Industry educational materials Legislation & legislative instruments Advertising hub Labelling & packaging Ingredients in therapeutic goods Exporting therapeutic goods Importing therapeutic goods Clinical trials Cosmetics International scientific guidelines Safety information for industry Medicine shortages Review of real world evidence and patient reported outcomes Advertising therapeutic goodsGetting started Complying with advertising requirements Learning resources Enforcement and outcomes News and reports Consultation and independent reviews Prescription medicinesAustralian Regulatory Guidelines for Prescription Medicines Prescription medicines regulation basics Standards and guidelines Forms for prescription medicine sponsors Regulatory decisions and notices Over-the-counter medicinesOTC medicines regulation basics Standards, guidelines and publications Forms for OTC medicine sponsors Regulatory decisions and notices Complementary medicinesComplementary medicine regulation basics Standards, guidelines and publications Forms for complementary medicine sponsors Complementary medicines reforms Regulatory decisions and notices SunscreensSunscreens regulation basics Standards, guidelines and publications Sunscreen reforms Medical devices & IVDsAustralian conformity assessment bodies Conformity assessment certificates, changes to requirements for certain medical devices Consent for Non-compliant Medical Device(s) - Frequently Asked Questions Determinations for Australian conformity assessment bodies Face masks and COVID-19 Medical devices regulation basics Overview of medical devices and IVD regulation Unique Device Identification system IVD medical devices regulation basics Standards, guidelines and publications Forms for medical device & IVD sponsors Medical devices reforms Regulatory decisions and notices BiologicalsAustralian Regulatory Guidelines for Biologicals Regulatory framework for biologicals Biological standards Forms for the biologicals industry Regulatory decisions and notices Blood and blood componentsRegulation of blood Regulation of platelet-rich plasma (PRP), platelet-rich fibrin (PRF) and conditioned serum Forms for the blood and blood components industry Other therapeutic goodsDisinfectants, sterilants and sanitary products Tampons & menstrual cups Manufacturing therapeutic goodsManufacturing basics Manufacturing medicines Manufacturing medical devices & IVDs Manufacturing biologicals Manufacturing blood and blood components Manufacturing inspections Forms for manufacturers Notices for manufacturers Notices about GMP clearance Guidance on the management of GMP compliance signals Scheduling of medicines & poisonsScheduling basics Scheduling committees meeting dates and decisions timeframes The Poisons Standard (the SUSMP) Public notices about scheduling State/Territory scheduling information About the TGATGA basicsWho we are & what we do What the TGA doesn't do Structure TGA plans & reports TGA reforms Publications Forms Freedom of information Acronyms & glossary TGA Internet site Social media Contact the TGAHow can we help? TGA customer service standards Report a perceived breach or questionable practices Website feedback or error reporting Translate this website Educational materialsFor consumers For health professionals For industry For university students Education priorities 2018-19 Compliance and enforcement hubCompliance management Compliance actions and outcomes News and information Report a breach Regulatory decisions & noticesConsent to import, supply or export goods that do not comply with standards Cancellation requested by the sponsor - regulatory actions Failure to pay annual charges - regulatory actions TGA laboratory testing results AUST numbers on medicine labels S19A approval notices CommitteesTGA statutory advisory committees Other committees Employment & job vacanciesWorking for the TGA Recruitment information Living in Canberra Fees and paymentsSchedule of fees and charges Payment options Information & notices about TGA fees & payments Cost recovery implementation statements Forms (fees and payments) Annual Charge Exemption (ACE) scheme TGA Business ServicesTGA Business services: getting started with the TGA TGA Business services - how to use the site TGA Business Services forms InternationalInternational activities International cooperation Use of international assessments TGA international engagement strategy Links to international agencies & organisations TGA Internet site archiveArchived behind the news articles Archived committee information Archived consultations & reviews Archived media releases Archived newsletters and articles Archived presentations Archived regulatory decisions & notices Archived TGA publications News roomNews & public noticesLatest news & updates Media releases & statements Behind the news Newsletters & articles Subscribe to updates TGA tenders TGA laboratory testing reports Consultations & reviewsOpen consultations & reviews Closed consultations & reviews About consultations Consultation forecast Medicines and Medical Devices Regulation Review Events, training & presentationsEvents & training Presentations BlogTGA topics Decrease the text size Increase the text size Print this page Share You are hereHome » About the TGA » International Links to international agencies & organisations Please see: Disclaimer: Links to external websites before using the links below. You might also like to know how to open a document or external link in a new browser window or tab. Regulatory agencies Canada: Health Canada Europe: European Medicines Agency (EMEA) New Zealand: New Zealand Medicines and Medical Devices Safety Authority (Medsafe) Singapore: Health Sciences Authority (HSA) United Kingdom: Medicines and Healthcare Products Regulatory Agency (MHRA) United States of America: US Food & Drug Administration (US FDA) International organisations ICMRA: International Coalition of Medicines Regulatory Authorities (ICMRA) IMDRF: International Medical Device Regulators Forum (IMDRF) PIC/S: Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) WHO: World Health Organization (WHO) The Therapeutic Goods Administration is part of the Health Products Regulation Group
Please see: Disclaimer: Links to external websites before using the links below.
You might also like to know how to open a document or external link in a new browser window or tab.
The Therapeutic Goods Administration is part of the Health Products Regulation Group