The document outlines the role and structure of the Therapeutic Goods Administration (TGA) in Australia, which regulates medicines and medical devices. It describes the TGA's responsibilities, including pre-market evaluation, post-market monitoring, and licensing of manufacturers, as well as the process for the approval and distribution of COVID-19 vaccines like Pfizer-BioNTech and Oxford-AstraZeneca. Additionally, it references the Australian Register of Therapeutics Goods (ARTG) and its significance in ensuring the safety and efficacy of therapeutic products.

1. N AM E : - S WA D H I N R O U T R AY
R E G D . N O . : - 2 1 6 1 6 11 0 0 5
M . P H AR M ( P H A R M A C E U T I C S )
G U I D E D B Y: - D R . R AJ A R A M M O H APAT R A
S U B . C O D E : - M P H 1 0 6 S / A
SEMINAR ON REGULATORY
AFFAIRS
TOPIC:- THERAPEUTIC GOODS
ADMINISTRATION

2. CONTENTS:-
• Introduction
• Role of TGA
• TGA structure
• Committees
• ARTG
• Regulation
• Covid-19 vaccine approval and distribution
• References

3. INTRODUCTION
• The Therapeutics Goods Administration(TGA) is a unit of the Australian
Government Department of Health and Ageing, is responsible for
administering the act.
• This act came into effect on 15th February 1991.
• TGA regulates the quality, supply and advertising of medicines, pathology
devices, medical devices, blood products and most other therapeutics. Any
items that claim to have a therapeutic effect, are involved in the
administration of medication.
• Essentially therapeutics goods must be entered on the Australia Register
of Therapeutics Goods(ARTG) before they can be supplied in Australia.(1)

4. ROLE OF THE TGA
• Pre – market evaluation and approval of registered products intended
for supply in Australia.
• Development, maintenance and monitoring of the systems for
listening of medicines;
• Licensing of manufacturers in accordance with international standards
of GMPs.
• Post market monitoring through sampling, adverse event reporting,
surveillance activities and response to public inquires.
• The assessment of medicines for export.

5. TGA STRUCTURE
• The TGA’s offices are grouped into three core groups- market
authorization group, monitoring and compliance group and
regulatory support group.(2)
1. TGA executive
2. Market authorization group(MAG)
3. Monitoring and compliance group(MCG)
4. Regulatory support group
5. Office of regulatory integrity(ORI)

6. COMMITTEES
The TGA is supported in its work by a number of external expert advisory committees,
including
1. Australian Drug Evaluation Committee (ADEC) – for prescription medicine.
2. Adverse Drug Reactions Advisory Committee
3. Medicine Evaluation Committee (MEC) – for the over- the- counter medicines.
4. Complementary Medicines Evaluation Committee(CMEC) – for complementary
medicines.
5. Therapeutic Devices Evaluation Committee (TDEC) – for medical devices.
6. Therapeutic Goods Committee (TGC)
(3)

7. AUSTRALIAN REGISTER OF
THERAPEUTICS GOODS (ARTG)
• A therapeutic good is boardly defined as a good which is represented in
any way to be taken , for therapeutic use.
• ARTG was established under the Therapeutics Goods Act 1989.
• ARTG is a computer database of therapeutic goods. Therapeutics goods
are divided into two classes: medicines and medical devices.
• AUST R – Higher risk medication, all prescription medicines, over–
the–counter products such as antiseptic , cough relief and colds.
• AUST L – Lower risk self medication products. Eg:- vitamin, mineral,
herbal and homeopathic products.

8. ELEMENT TO REGULATE THERAPEUTIC
GOODS
 Licensing and audit of manufactures
 Pre-market assessment
 Post- market regulatory authority
LICENSING AND AUDIT OF MANUFACTURERS
The act requires each Australian manufacturers of medicinal
products for human use to hold a manufacturing license. License holder
are required to comply with the manufacturing principles of the act.

9. PRE- MARKET ASSESSMENT
Premarket assessment consists of two key components:
• Conformity assessment - an independent check that the processes
undertaken by a manufacturer ensure that a medical device complies
with the regulatory requirements for quality, safety and performance;
followed by
• An application (and decision) to include the medical device in the
ARTG.
 Listed medicines are low risk medicines and are included on the ARTG
via a low- cost and streamlined electronic application and validation
process.

10. POST- MARKET REGULATORY
AUTHORITY
• Once a medical device has been included in the ARTG the device must
continue to meet all the regulatory, safety and performance requirements
and standards that were required for the approval.
• The TGA has mandatory requirements and ongoing responsibilities for
all manufacturers and sponsors of medical devices.
• Information received by the TGA once a device is included in the ARTG
informs actions including:
Corrective actions including, but not limited to, changes to device
design, construction and information accompanying the device;
Suspension and/or cancellation of the product;
Recall actions including safety alerts; and
Educational resources including website notifications.

11. The following pages contain information relating to ongoing post-market
responsibilities and activities for sponsors and manufacturers:
• Sponsor's ongoing responsibilities
• Distribution records
• Manufacturer's ongoing responsibilities
• Adverse event reporting - sponsors
• Report an adverse event - health professionals and consumers
• Adverse event reporting form - sponsors
• Post market reviews
• Post market review compliance dashboard
• Annual reports
• Changing the sponsor/transferring therapeutic goods
• Recalls

12. COVID-19 VACCINE APPROVAL AND
DISTRIBUTION
Pfizer– BioNtech vaccine
• On 25 January 2021, the TGA provisionally approved the two-
dose Pfizer- BioNtech vaccine, named COMIRNATY, for use
within Australia. The provisional approval only recommends the
vaccine for patients over the age of 16, pending ongoing submission
of clinical data from the vaccine sponsors(the manufacturers, Pfizer
and BioNtech). Additionally, every batch of vaccines have their
composition and documentation verified by TGA laboratories before
being distributed to medical providers.

13. • The Department of Health planned the administration of COVID-19
vaccinations in five phases, organized by the risk of exposure. Border,
quarantine, and front-line health and aged care workers were vaccinated
first, followed by over 70 year-olds, other health care workers, and essential
emergency service members. Following the provisional approval of
COMIRNATY, Prime Minister Scott Morrison said that it was planned for the
first group to begin vaccinations by February 2021, six weeks earlier than
originally planned.
• The first public COVID-19 Vaccine in Australia actually took place on
21 February 2021 with the Pfizer– BioNTech vaccine at Castle hill in Sydney.
• On 23 July 2021, the TGA approved the Pfizer COVID-19 vaccine for
teenagers between 12 to 15 years old.
• On 5 December 2021, the TGA provisionally approved the Pfizer COVID-19
vaccine access for five to 11-year-olds. (4)

14. Oxford–AstraZeneca vaccine
• On 16 February 2021, the Oxford–AstraZeneca vaccine was approved by the
TGA for use in Australia. The administration of this vaccine is scheduled to
start in March.
• Two weeks later, on 28 February, the first shipment of the vaccine, around
300,000 doses, arrived at Sydney for rollout from 8 March. On 5 March 2021,
Italy stopped the export of AstraZeneca vaccine to Australia due to their
slower rollout of that vaccine in the EU.
• On 23 March, TGA approved the first batch of locally manufactured
AstraZeneca vaccine by CSL-Seqirus in Melbourne, and 832,200 doses were
ready for rollout in the following weeks. (5)

15. REFERENCES
1. "TGA basics". Therapeutic Goods Administration. Retrieved 25
January 2021.
2. "Structure". Therapeutics Goods Administration. 16 October 2020.
Retrieved 25 January 2021
3. "Committees". Therapeutic Goods Administration. Retrieved 25
January 2021.
4. Worthington, Brett "Australia secures additional Pfizer vaccine following
AstraZeneca concerns” Retrieved 9 April 2021.
5. Haydar, Nour "Federal government projects little need for AstraZeneca
COVID-19 vaccine after October” Retrieved 24 June 2021.
WEBSITES:-
1. https://www.tga.gov.au/
2. tga.gov.au/covid-19-vaccine-pfizer-australia-comirnaty-tozinameran-mrna
3. https://odc.gov.au/