The Therapeutic Goods Administration (TGA) is a unit of the Australian Government Department of Health and Ageing that regulates therapeutic goods including medicines and medical devices. The TGA ensures these goods available in Australia meet acceptable standards of quality, safety and efficacy through a risk-based regulatory framework. It has over 700 staff from varied backgrounds including pharmacists, scientists, and medical officers. The TGA operates under the Therapeutic Goods Act of 1989 to provide a national framework for regulating therapeutic goods and maintains the Australian Register of Therapeutic Goods which lists goods approved for supply or export from Australia.

1. Therapeutic Good
Administration
Australia [TGA]
PRESENTEDBY…
SAKSHI R. YADAV
SKBCOP,KAMPTEE

2. INTRODUCTION OF TGA
• The Therapeutic Goods Administration (TGA) is a unit of the Australian
Government Department of Health and Ageing.
• The TGA monitoring activities to ensure therapeutic goods available in Australia
are of an acceptable standard.
• The regulatory framework within which the TGA operates is based on a risk
management approach. It is designed to ensure public health and safety.
• It is beneficial for both consumers and industry.
• In undertaking its responsibility, the TGA has developed a constructive partnership
with industry at the same time freeing industry from any unnecessary regulatory
burden and minimizing the cost of medicines.

3. •'Therapeutic goods' may be:
Medicines, or
Medical devices
•Some products will be classified as a medicine or as a food or cosmetic depending
on how that particular product fits with the criteria set out in the Act.
•TGA also includes 700 staffs including
Pharmacist
Scientist
Toxicologist
Technitions
Medical officers
Investigators accountants
Lawyers
Inspectors

4. ObjeCTIves :
• First objective of this hormonisation is to maintain clarity and
consistency to support quality use of medicines.
• Second objective to minimize administration costs for
industry, thereby supporting of supplying medicines to
australian consumers and internationally.

5. What is therapeutic Goods?
• Therapeutic good is a product for use in humans that is used in, or in connection
with Preventing, diagnosing, curing a disease, defect or injury
OR
• Influencing, inhibiting or modifying a physiological process
OR
• Testing the susceptibility of persons to a disease
OR
• Influencing, controlling or preventing conception
OR
• Testing for pregnancy.

6. tGa structre
• It is comes from Health Product Regulating Group in Australian
Government Department Of Health .
• HPRG also include Office of Drug Control.
• TGA Structure are as follows :-
 The TGA Regulatory offices are grouped into :
1. Market Authorisation Group
2. Monitoring and Compliance Group
3. Regulatory Support Group
 TGA Executive:
The TGA Executive has overall responsibility for the management of the TGA's
regulatory activities.

7. 1. Market Authorization Group:-
The Market Authorization Group is responsible for the evaluation and authorization
of therapeutic goods to ensure they meet appropriate standards of quality, safety
and efficacy.
2. Monitoring and Compliance Group:-
The Monitoring and Compliance Group is responsible for monitoring of therapeutic
goods on the Australian market to ensure that they comply with required
standards of quality, safety, efficacy.
3. Regulatory Support Group:-
The Regulatory Support Group provides the business systems and support services
that help the TGA to undertake its regulatory responsibilities.
• Office of Regulatory Integrity:-
• The Office of Regulatory Integrity functions as an internal auditor of regulatory
activity and advises the TGA Executive on the appropriate operations

8. therapeutic Goods act 1989
 Therapeutic Goods Act 1989, is to provide a national framework
for the regulation of therapeutic goods in Australia to
 Ensure the Quality, Safety and Efficacy of medicines ;
 Ensure the quality, safety and performance of medical devices.
 The Act is a Common wealth Act that provides a uniform national system
of controls over therapeutic goods.
 Facilitating trade between the States/Territories and benefiting for both
consumers and industry.
 Essentially therapeutic goods must be entered on the Australian Register
of Therapeutic Goods (ARTG) before they can be supplied in Australia.
 The ARTG is a computer database of information about therapeutic
goods for human use approved for supply in, or exported from Australia.

9. Regulation of Medicines
 The Therapeutic Goods Administration overall control the of supply of
medicines in Australia is exercised through following main processes:
1. Pre-market evaluation and approval of medicines intended for supply in
Australia.
2. Development, maintainance and monitoring of non-prescriptional drugs.
3. Licensing of manufacturers in accordance with international standards
under Good Manufacturing Practice .
4. Post-market monitoring, through sampling, adverse event reporting,
surveillance activities, and response to public inquiries .
5. Assessment of medicines for export.

10. Regulation of Medicine in austRelia
• In Australia, medicines can be classified as:
tHeRaPeutic goodstHeRaPeutic goods
MEDICINEMEDICINE MEDICAL DEVICEMEDICAL DEVICE
REGISTEREDREGISTERED LISTEDLISTED
NON-
PRESCRIPTION
NON-
PRESCRIPTION
PRESCRIPTIONPRESCRIPTION
COMPLEMENTARY
MEDICINE
COMPLEMENTARY
MEDICINE
OTC MEDICINE(NON-
COMPLEMENTARY)
OTC MEDICINE(NON-
COMPLEMENTARY)
LISTED NON-
PRESCRIPTION
MEDICINE
LISTED NON-
PRESCRIPTION
MEDICINE

11. austRelian RegisteR foR tHeRaPeutic
good
• The Australian Register of Therapeutic Goods is a database of
information about therapeutic goods which are approved for supply in
or export from Australia.
• The sponsors of registered medicines are required to provide
comprehensive safety, quality and efficacy data.
• sponsors of listed medicines are required to provide data on safety and
quality only.

12. Always read the labels on medicines
– Check to see if there is an AUST R or AUST L number.
– Unless it has been prescribed by a doctor, check the medicine's uses to make sure
they are suitable for your needs.
– Read carefully all directions and warnings, and always follow
them.
– Check the storage conditions including the recommended
temperature.
– Check the expiry date. When the date is reached, safely dispose of any remaining
medicine.
– See if the batch number and supplier's name and address are
visible.
3504/28/16 SAGAR SAVALE