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THERAPEUTIC
GOODS
ADMINSTRATION
(TGA) PRESENTED BY:
PRANALI .M. PALANDURKAR
UNIVERSITY DEPARTMENT OF
PHARMACEUTICAL SCIENCES
R.T.M.N.U NAGPUR
CONTENTS
 INTRODUCTION
 OBJECTIVE
 ROLE OF TGA
 ORGANIZATION
 WHAT DOES IT REGULATE
 STATUTORY ADVISORY COMMITTEES
2
INTRODUCTION
 The Therapeutic Goods Administration (TGA) is part of the Australian Government
Department of Health and Ageing, and is responsible for regulating medicines and medical
devices.
 The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk
management approach designed to ensure therapeutic goods supplied in Australia meet
acceptable standards of quality, safety and efficacy (performance), when necessary.
 TGA came into effect on 15 February 1991.
 It is responsible for regulating therapeutic goods including prescription medicines, vaccines,
sunscreens, vitamins and minerals, medical devices, blood and blood products.
3
OBJECTIVE
 To safeguard and enhance the health of the Australian community through the effective
and timely regulation of therapeutic good.
 To provide a national framework for the regulation of therapeutic goods in Australia to
ensure the quality, safety and efficacy of medicine and ensure the quality ,safety and
performance of medical devices.
 Essentially therapeutic goods must be entered on the Australian Register of Therapeutic
Goods (ARTG) before they can be supplied in Australia.
4
ROLE OF TGA
The TGA carries out an overall control through five main processes:
 Pre-market evaluation and approval of registered products intended for supply in Australia.
 Development ,maintenance and monitoring of the systems for listing 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 inquiries.
 The assessment of medicines for export.
5
ORGANIZATION
TGA Executive
Market authorization
Group
(MAG)
Monitoring
&compliance
group(MCG)
Regulatory support
group
6
 TGA Executive
TGA executive has overall responsibility for the management of the TGA’s
regulatory function activities. It comprises of:
 TGA national manager
 Principal medical adviser
 Principal legal adviser
 Chief regulatory officer
 Chief operating officer
7
 Market authorization group
 Responsible for undertaking evaluations of application to approve new therapeutic
products for supply in Australia.
 MAG makes decisions whether to approve or reject market authorization of
medicines, medical devices and blood and tissue that are imported, exported,
manufactured and supplied in Australia.
8
 Monitoring and compliance group
 Responsible for ongoing monitoring of therapeutic products approved
for supply in Australia to ensure they meet the necessary standards
throughout their lifecycle .
9
 Regulatory support group
 Provides whole-of-agency regulatory support services to the TGA, this
includes the legal, finance ,information technology and information
management, communication, parliamentary and human resource
management services.
10
WHAT TGA REGULATES?
The TGA regulates the supply of:
 Medicines prescribed by a doctor or dentist
 Medicines available from behind the pharmacy counter
 Medicines available in the general pharmacy
 Medicines available from supermarkets
 Complementary medicines, these include vitamins, herbal and traditional medicines
 Medical devices, from simple devices like bandages to complex technologies like heart Pacemakers
 Products used to test for various diseases or conditions (in vitro diagnostic devices), such as blood
tests; and
 Vaccines, blood products, and other biologics.
 And the manufacturing and advertising of these products.
11
 Regulating medicines-The regulation of medicines includes the following features:
 Classifying the medicine .
 Implementing controls for the manufacturing processes of medicines
 Medicines assessed as having a higher level of risk (are evaluated for quality, safety and
efficacy
 Ingredients in medicines with a lower risk are assessed for quality and safety
 Lawful supply medicine .
 TGA monitoring includes a comprehensive adverse event reporting programme.
12
 Regulating medical devices -The regulation of medical devices includes:
 Classifying the medical device based on different levels of risk to the user
 Assessing compliance for their quality, safety and performance
 Implementing regulatory controls for the manufacturing processes of
medical devices
 Including the medical device in the Australian Register of Therapeutic
13
 Other therapeutic goods regulated by the TGA
The TGA also applies a risk management approach to the regulation of:
 In vitro diagnostic medical devices (IVDs)
 blood
 blood components
 plasma derivatives
 tissue and cellular products
 tissue and cell based derivatives
 sterilants and disinfectants
14
TGA STATUTORY ADVISORY COMMITTEES
This committees call upon to obtain independent advice on scientific & technical matters
 Advisory committee on Biological (ACB)
 Advisory committee on Complementary medicine (ACCM)
 Advisory committee on Medical devices (ACMD)
 Advisory committee on Non –prescription medicine (ACNM)
 Advisory committee on Prescription medicine (ACPM)
 Advisory committee on safety of medical devices (ACSMD)
 Advisory committee on safety of medicine (ACSOM)
 Advisory committee on safety of vaccines(ACSOV)
 Therapeutic goods committee (TGC)
15
THANK YOU
16

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Therapeutic goods adminstration

  • 1. THERAPEUTIC GOODS ADMINSTRATION (TGA) PRESENTED BY: PRANALI .M. PALANDURKAR UNIVERSITY DEPARTMENT OF PHARMACEUTICAL SCIENCES R.T.M.N.U NAGPUR
  • 2. CONTENTS  INTRODUCTION  OBJECTIVE  ROLE OF TGA  ORGANIZATION  WHAT DOES IT REGULATE  STATUTORY ADVISORY COMMITTEES 2
  • 3. INTRODUCTION  The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices.  The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary.  TGA came into effect on 15 February 1991.  It is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products. 3
  • 4. OBJECTIVE  To safeguard and enhance the health of the Australian community through the effective and timely regulation of therapeutic good.  To provide a national framework for the regulation of therapeutic goods in Australia to ensure the quality, safety and efficacy of medicine and ensure the quality ,safety and performance of medical devices.  Essentially therapeutic goods must be entered on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. 4
  • 5. ROLE OF TGA The TGA carries out an overall control through five main processes:  Pre-market evaluation and approval of registered products intended for supply in Australia.  Development ,maintenance and monitoring of the systems for listing 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 inquiries.  The assessment of medicines for export. 5
  • 7.  TGA Executive TGA executive has overall responsibility for the management of the TGA’s regulatory function activities. It comprises of:  TGA national manager  Principal medical adviser  Principal legal adviser  Chief regulatory officer  Chief operating officer 7
  • 8.  Market authorization group  Responsible for undertaking evaluations of application to approve new therapeutic products for supply in Australia.  MAG makes decisions whether to approve or reject market authorization of medicines, medical devices and blood and tissue that are imported, exported, manufactured and supplied in Australia. 8
  • 9.  Monitoring and compliance group  Responsible for ongoing monitoring of therapeutic products approved for supply in Australia to ensure they meet the necessary standards throughout their lifecycle . 9
  • 10.  Regulatory support group  Provides whole-of-agency regulatory support services to the TGA, this includes the legal, finance ,information technology and information management, communication, parliamentary and human resource management services. 10
  • 11. WHAT TGA REGULATES? The TGA regulates the supply of:  Medicines prescribed by a doctor or dentist  Medicines available from behind the pharmacy counter  Medicines available in the general pharmacy  Medicines available from supermarkets  Complementary medicines, these include vitamins, herbal and traditional medicines  Medical devices, from simple devices like bandages to complex technologies like heart Pacemakers  Products used to test for various diseases or conditions (in vitro diagnostic devices), such as blood tests; and  Vaccines, blood products, and other biologics.  And the manufacturing and advertising of these products. 11
  • 12.  Regulating medicines-The regulation of medicines includes the following features:  Classifying the medicine .  Implementing controls for the manufacturing processes of medicines  Medicines assessed as having a higher level of risk (are evaluated for quality, safety and efficacy  Ingredients in medicines with a lower risk are assessed for quality and safety  Lawful supply medicine .  TGA monitoring includes a comprehensive adverse event reporting programme. 12
  • 13.  Regulating medical devices -The regulation of medical devices includes:  Classifying the medical device based on different levels of risk to the user  Assessing compliance for their quality, safety and performance  Implementing regulatory controls for the manufacturing processes of medical devices  Including the medical device in the Australian Register of Therapeutic 13
  • 14.  Other therapeutic goods regulated by the TGA The TGA also applies a risk management approach to the regulation of:  In vitro diagnostic medical devices (IVDs)  blood  blood components  plasma derivatives  tissue and cellular products  tissue and cell based derivatives  sterilants and disinfectants 14
  • 15. TGA STATUTORY ADVISORY COMMITTEES This committees call upon to obtain independent advice on scientific & technical matters  Advisory committee on Biological (ACB)  Advisory committee on Complementary medicine (ACCM)  Advisory committee on Medical devices (ACMD)  Advisory committee on Non –prescription medicine (ACNM)  Advisory committee on Prescription medicine (ACPM)  Advisory committee on safety of medical devices (ACSMD)  Advisory committee on safety of medicine (ACSOM)  Advisory committee on safety of vaccines(ACSOV)  Therapeutic goods committee (TGC) 15