What is TGA ?

Y Ú



 
ý hich
came into effect on 15 February 1991

Y To provide a national frameork for the

regulation of therapeutic goods in Australia to
ensure the quality, safety and efficacy of
¸
  and ensure the quality, safety and
performance of ¸

 
Y The Ú 
 
 
¸  Ú 
is a unit of the    ¸ 

 ¸     
  and is
responsible for administering the provisions of
the legislation.

Y Éssentially therapeutic goods must be entered

on the      Ú 


 Ú  before they can be supplied in
Australia
 What is a therapeutic good ?

Y A 'therapeutic good' is broadly defined as a

good hich is represented in any ay to be, or
is likely to be taken to be, for therapeutic use
(unless specifically excluded or included under
Section 7 of the Ú



  m
   Ú 
 
Y The TGA carries out a range of assessment and monitoring activities to
ensure therapeutic goods available in Australia are of an acceptable
standard ith the aim of ensuring that the Australian community has
access, ithin a reasonable time, to therapeutic advances.
1. Regulation of therapeutic goods in Australia
The regulatory frameork is based on a risk management approach
designed to ensure public health and safety, hile at the same time freeing
industry from any unnecessary regulatory burden
2. A history of therapeutic goods regulation in Australia
Publication capturing the long history of the evolution of therapeutic
products regulation in Australia
3. Australian register of therapeutic goods (ARTGm
What it is and ho to vie it
4. Medicines regulation and the TGA
A general introduction to the regulatory process for medicines in Australia
5. The TGA's risk management approach
Describes the TGA's role in the management of risks associated ith
medicines, medical devices, blood and tissues
6. TGA Nes
Nesletter produced 3 times a year
 Ú 
 

¸ 
  
Y National Manager: Dr Rohan Hammett
Y Principal Medical Adviser: Dr Ruth Lopert
Business Management Group
Éxecutive Support Unit
Office of Complementary Medicines
Office of Devices, Blood and Tissues
Office of Laboratories and Scientific Services
Office of Manufacturing Quality
Office of Medicines Safety Monitoring
Office of Non Prescription Medicines
Office of Prescription Medicines
 Regulations by TGA
|   ¸
 
Prescription medicine products
Complementary medicines
Disinfectants
OTC products

|    





|   ¸

 

| ¸  

Complementary medicines (TGAm

er s Vitamins Minerals

Nutritional
omoeopathic Aromatherapy

supplements medicines products

Traditional Other
Ayurvedic
Chinese Traditional
Medicines
Medicines Medicines
Y TGA has developed the     

   ¸
 ¸   
 
  to assist sponsors of complementary
medicines to meet their legislative obligations

Y TGA maintains the     

Ú 
 
 Ú , a database that
includes details of all therapeutic goods that
are imported into, supplied in, or exported
from Australia
  
 


Y The regulation of complementary medicines in Australia an overvie
Y Australian regulatory guidelines for complementary medicines (ARGCMm
Y ngredients/excipients
Y Compositional guidelines
Y Énforcement guidelines
Y Specific products/substances
Y Approved terminology for medicines
Y Section 7 declarations food or therapeutic good?
Y Guidelines for levels and kinds of evidence to support indications and
claims
Y Éuropean Union guidelines
Y Pharmacovigilance & reporting adverse drug reactions
Y Ho do  determine hether my product is a therapeutic product?
| For complimentary medicines TGA developed
1. %   
     

¸
 ¸   ¸
 

2. ! 

  
    


¸
 ¸   ¸
 
P  


 P is currently the
source of official standards, The BP is
supplemented by Ú



 

Ú 
3. É  
¸
 ¸   ¸
 
The indications and claims are true, valid
and not misleading
TGA has developed the 

 
 


 





 

  to assist sponsors in determining
the level of evidence required to support
indications and claims made for
complementary medicines.
| 
 
 
  "

Australian 'P
' scheme covers all

medicines and most health professionals
Publication of a report in the 


 

 P
 or medical
journals to raise aareness of the reaction
and/or removal of the product from the
market
| 
 

#Úherapeutic goods in Australia is subject to

the advertising requirements of the Act
(hich adopts the Ú







 Ú !"##$m and the
supporting Regulations, the Ú


%& and other relevant las.
 Regulation of prescription medicines
Y nclude a ne medicine in the ARTG
applicable to medicines that are evaluated by
the Drug Safety and Évaluation Branch (DSÉBm
of the TGA

Y CTD format for the documentation of data on

the quality, non clinical and clinical aspects of
medicines
 
  

 

¸
  

Y Æ

'Administrative nformation and
Prescribing nformation For Australia and

Y 

"P'Notice to Applicants: Medicinal
products for human use, Presentation and
format of the dossier CTD
Regulation of Disinfectants & Sterilants
Y Therapeutic Goods Order No 54 Standard for
Disinfectants and Sterilants (TGO 54m

Y Registrable goods :
sterilants, instrument grade disinfectants, and
hospital or household/commercial grade
disinfectants
 p

 



'
’ commercial history, regulatory actions and regulatory status
’evidence of GMP compliance of overseas
manufacturers/licensing of Australian manufacturers may be
required at a later date.
’ risk analysis
’ formulation and physical/chemical properties including
stability
’ microbial efficacy
’ toxicity/residues
’ effects of sterilant or disinfectant on devices
’ container/packaging
’ labelling
Y p

 

 ( 




)

 


Y microbial efficacy (as relevant to specific

claimsm
Y formulation
Y container packaging (materials related onlym
Y labelling
 Regulation of blood
| Under the Act '
' means hole blood
extracted from human donors and '

¸
 ' means therapeutic components
that have been manufactured from blood
(including red cells, hite cells, progenitor cells,
platelets and plasmam

| Blood and blood components and plasma must

be manufactured in compliance ith
the  


 Æ 
 * P

 
Ú

Y Therapeutic Goods Order 75 % 

*



 


 
 

 


 P

 states that haematopoietic

progenitor cells derived from cord blood must
meet the requirements of the document
entitled+,

 % 
 

P

 


ý 

ý Ú
ý Pý
%


ý  


+ published by the
Foundation for the Accreditation of Cellular
Therapy and NetCord and ¸ 



   
 $%
 Regulation of tissues
| Human tissue for implantation in the human
body that is obtained, stored and supplied
ithout any deliberate alteration to its biological
and mechanical properties must comply ith
the  




 Æ

ý * P

  Ú


| ncludes most banked tissue, such as Dura mater,

heart valves, skin, corneas and bone.
| Human derived tissue and cell products that

Y Are not regulated as medicines; and

Y Are produced by deliberate alteration of tissue or cells in
defined manufacturing processes

are being regulated as "therapeutic devices" and

declared other therapeutic goods (OTGsm
by Ú



  
   

 Æ




 Medical devices
Y Defined in the legislation as ͞any instrument,
apparatus, appliance, material or other article
intended by the person under hose name it
is to be supplied, to be used for human beings
for the purposes of

Y Diagnosis, prevention, monitoring, treatment

or alleviation of disease
| 

 

ý P

  Ú
 PÚ is
the area ithin the TGA responsible for
regulating medical devices

| Æ
 

 -

 



Æ- hich provides advice to the Minister
on issues relating to the safety, quality,
performance and timely availability of medical
devices
| Classification of Medical Devices based on:
Manufacturer͛s intended use
Level of risk; and
Degree of invasiveness in the human body

  ¸

 :

| Class 
| Class a
| Class b
| Class 
| Active mplantable Medical Devices (AMDm
Y Fe examples are :
Beds (class m
Anaesthetic Breathing circuits (class am
Dental filling materials (class am
Anaesthetic machines (class bm
Apnea monitors (class bm
Absorbable sutures (class m
Breast implants (class m
mplantable drug infusion devices (AMDm
mplantable pulse generator (AMDm
Y Higher class devices undergo a more stringent
form of conformity assessment than loer
class devices

Y Certification by the TGA or an overseas

notified body is required for higher risk
devices
 Post marketing vigillence
| To maintain consumer confidence in the quality, safety
and effectiveness of medicines supplied in Australia

| Targeted and random laboratory testing of products

and ingredients

| Targeted and random surveillance in the market place

| An effective, responsive and timely recalls procedure

Y Audit of GMP

Y Targeted and random desk based audits of

Listed products

Y Monitoring of adverse reactions to

complementary medicines

Y Éffective controls for the advertising of

therapeutic goods
 RÉFÉRÉNCÉS
| .tga.gov
| http://.tga.gov.au/docs/html/eugctd.html
| http://.tga.gov.au/legis/index.htm#ausleg
| http://.tga.gov.au/contact.htm#med
| http://.tga.gov.au/docs/html/devguid9.htm
| http://.tga.gov.au/docs/html/orphan.htm
| http://.tga.gov.au/pmeds/pmeds.htm#guide
lines