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January 2021

ICMRA statement for healthcare professionals: How COVID-19 vaccines will be regulated for safety and effectiveness

22 January 2021

Healthcare professionals and public health authorities will have a central role in discussing vaccination against COVID-19 with their patients.
Ergometrine maleate injection (500 microgram/mL) ampoule

21 January 2021

Alternative product approved to address expected shortage
Advisory Committee on Vaccines (ACV)

21 January 2021

Updated 2021 proposed meeting dates
Provisional registration extension and transition to full registration

21 January 2021

Guidance now includes advice on lodgement of provisional variation applications
Update to listed medicines indications in January 2021

21 January 2021

The Therapeutic Goods (Permissible Indications) Determination has been updated
TGA grants additional provisional determination for a COVID-19 vaccine

20 January 2021

The TGA has granted a provisional determination to Biocelect Pty Ltd (on behalf of Novavax Inc.) in relation to the COVID-19 Vaccine, NVX-CoV2373.
Face masks and COVID-19

19 January 2021

New Consumer information relating to face masks
Face masks and respirators that are regulated by the TGA

19 January 2021

Updated information relating to the advertising of face masks
Pharmacovigilance obligations of medicine sponsors

19 January 2021

Answers to frequently asked questions in relation to the pharmacovigilance obligations of sponsors of medicines on the ARTG
Video: TGA regulatory compliance

18 January 2021

Watch this video for an overview of the TGA compliance framework
Post-market review of face masks: Outcomes and actions

18 January 2021

Update to list of face masks which are subejct to market actions
Prescription medicines: new or extended uses, or new combinations of registered medicines

18 January 2021

2 medicine registrations added
Prescription medicines: registration of new generic medicines and biosimilar medicines

18 January 2021

8 medicine registrations added
Prescription medicines: registration of new chemical entities in Australia

18 January 2021

1 medicine registration added
Norwegian investigation of COVID-19 vaccination risks for elderly, very frail patients

17 January 2021

In recent days the TGA has received reports of about 30 deaths in over 40,000 elderly individuals in Norway vaccinated with the Pfizer BioNTech vaccine
Regulation of software based medical devices

15 January 2021

Information and guidance on the regulation of Software as a Medical Device
Prescription medicines: applications under evaluation

15 January 2021

A list of applications for new medicines or new uses for existing medicines that are currently under evaluation by the TGA
Database of section 19A approvals to import and supply medicines to address medicine shortages

15 January 2021

Section 19A database has been updated to include new approvals
Adverse event reporting

15 January 2021

Updated information regarding IMDRF adverse event reporting codes
Advice for health procurement teams about therapeutic goods and medical devices

14 January 2021

Guidance for procurement areas in hospitals, aged care residential facilities and other facilities
Medicines containing Eucommia ulmoides (known as Du-Zhong or Tu-chung)

13 January 2021

Safety advisory – contains latex (statement includes Chinese translation 中文翻译)
Ability of COVID-19 tests to detect emerging genetic variants of SARS-CoV-2

13 January 2021

The TGA is undertaking a post-market review of all Point of Care and Laboratory tests included in the ARTG, which are intended to identify patients with COVID-19, to ensure they can detect the emerging SARS-CoV-2 genetic variants and remain accurate
Consultation: Proposal to remove redundant processes for entering certain formulation information into a therapeutic goods application

13 January 2021

TGA is seeking feedback on a proposal to streamline how information about certain therapeutic goods formulations is entered into TGA electronic systems when seeking market approval. Closing date: 24 February 2021
AusPAR: Iodised oil

12 January 2021

Australian Public Assessment Report for Iodised oil
TGA stakeholder survey 2020

11 January 2021

Results report for the 2020 TGA stakeholder survey
Consultation: Australian Regulations definition of Central Circulatory System (CCS)

11 January 2021

TGA is reviewing the Australian definition of the CCS and is requesting further feedback in relation to this definition, to determine whether any changes should be made. Closing date: 10 February 2021
ACV meeting statement, meeting 17, 2 December 2020

7 January 2021

Advisory Committee on Vaccines meeting statement
ACV meeting statement, Meeting 16, 30 September 2020

7 January 2021

Advisory Committee on Vaccines meeting statement
Importing personal protective equipment into Australia during the COVID-19 pandemic

4 January 2021

What you need to know before you seek to import personal protective equipment (PPE) into Australia during the COVID-19 pandemic

Last month's news & updates

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Latest news & updates

Related information

January 2021

ICMRA statement for healthcare professionals: How COVID-19 vaccines will be regulated for safety and effectiveness

Ergometrine maleate injection (500 microgram/mL) ampoule

Advisory Committee on Vaccines (ACV)

Provisional registration extension and transition to full registration

Update to listed medicines indications in January 2021

TGA grants additional provisional determination for a COVID-19 vaccine

Face masks and COVID-19

Face masks and respirators that are regulated by the TGA

Pharmacovigilance obligations of medicine sponsors

Video: TGA regulatory compliance

Post-market review of face masks: Outcomes and actions

Prescription medicines: new or extended uses, or new combinations of registered medicines

Prescription medicines: registration of new generic medicines and biosimilar medicines

Prescription medicines: registration of new chemical entities in Australia

Norwegian investigation of COVID-19 vaccination risks for elderly, very frail patients

Regulation of software based medical devices

Prescription medicines: applications under evaluation

Database of section 19A approvals to import and supply medicines to address medicine shortages

Adverse event reporting

Advice for health procurement teams about therapeutic goods and medical devices

Medicines containing Eucommia ulmoides (known as Du-Zhong or Tu-chung)

Ability of COVID-19 tests to detect emerging genetic variants of SARS-CoV-2

Consultation: Proposal to remove redundant processes for entering certain formulation information into a therapeutic goods application

AusPAR: Iodised oil

TGA stakeholder survey 2020

Consultation: Australian Regulations definition of Central Circulatory System (CCS)

ACV meeting statement, meeting 17, 2 December 2020

ACV meeting statement, Meeting 16, 30 September 2020

Importing personal protective equipment into Australia during the COVID-19 pandemic

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