complete review of Regulatory guidelines of Australia...

1. REGULATORY GUIDELINES OF
AUSTRALIA
Submitted by-
Pradeep Gusain
Msc. Clinical Research

2. • The Australian pharmaceutical industry is the largest funder of medical
research
• It is the second most innovative manufacturing industry in Australia.
• It approximately takes on an average of 15 years for the R and D of a new
medicine
• only three in 10 approved medicines may produce sales that match or
exceed the average R&D.
2

3. Therapeutic Goods-
(As per Therapeutic Goods Act 1984)
A good which can be a medicine or a medical device which is represented in any
form and is of any use.
It is used in connection with-
1. preventing, diagnosing, curing or alleviating a disease,
2. ailment, defect or injury; or
3. influencing, inhibiting or modifying a physiological process;
4. testing the susceptibility of persons to a disease or ailment;
5. influencing, controlling or preventing conception.
6. testing for pregnancy
7. replacement or modification of parts of the anatomy.
3

4. CLASSIFICATION OF THERAPEUTIC GOODS
4

5.  Medicines
As per Australian Register of Therapeutic Goods
-It is a database of information about therapeutic goods
which are approved for supply in or export from Australia.
Medicines are classified as 1. Registered Medicines(low risk)
2. listed medicines(high risk)
Registered Medicines
1.the level of assessment and the
degree of regulation are more
rigorous and detailed.
2.The sponsors provides
comprehensive safety, quality and
efficacy data.
Listed Medicines
1. Sponsors of listed
medicines are required to
provide data on safety and
quality only.
5

6. RISK RELATIONSHIP BETWEEN MEDICATIONS
6

7. 7

8. CONTINUED
8

9. A BRIEF OVERVIEW OF STEPS FOR THE
REGULATION IN AUSTRALIA
FIRST STEP
•All the medicines registered or listed is submitted to a pre-market
•Assessment.
•The degree of control is directly related to the risk level of the medicine.
SECOND STEP
•All Australian manufacturers are required to hold a licence which certifies
compliance with the Code of GMP’s.
THIRD STEP
•The post-market vigilance activities such as investigating problems, conducting
inspections of manufacturing sites etc are carried out by the TGA and relevant
Committees.
9

10. FOURTH STEP
• Both scientific evidence and evidence of traditional used to support
therapeutic claims.
• Consumers are not denied to use some useful traditional medicines
•Simultaneously, they are alerted that these medicines have not undergone
any scientific assessment.
CONTINUED
10
The main piece of legislation governing medicines in Australia is the Therapeutic
Goods Act 1989
It establishes a national system of controls for medicines.
It is supported by the Therapeutic Goods Regulations and other state/territory
legislation.
NOTE

11. ingredients(usually having long
history of use)
enlisted in the Australian
Register of Therapeutic Goods
Ingredients not scheduled in the
Standard for Uniform Scheduling
of Drugs and Poisons
LISTED MEDICINES
Low risk medicines
STEPS FOR ENLISTMENT IN AUSTRALIAN REGISTER OF
THERAPEUTIC GOODS
1. assessed by TGA for safety and quality but not efficacy.
2. the products are assessed by sponsors against standards defined by the
TGA.
3. The assessment is then subjected to a simple 'eligibility review‘.
4. If it passes, the sponsor receives a confirmation letter from the TGA
5. Thus, then the medicines gets listed in the Australian Register of
Therapeutic Goods.
11

12. • These medicines carry claims of efficacy.
• CLASSIFICATION
a) non-prescription (low risk) registered medicines-
OTC medications like analgesics etc.
a) prescription (high risk) registered medicines-
Mainly injectables like insulin for diabetes, only by prescription.
They are assessed by the TGA
for safety, quality and efficacy.
They usually contains(not necessarily)
substances scheduled in Standard for
Uniform Scheduling of Drugs and
Poisons.
REGISTERED MEDICINES
12

13. NOTE- for ‘Export Only' Medicines
they are enlisted in Australian Register of Therapeutic Goods.
Not to be registered irrespective of ingredients and therapeutic claims made.
Complementary medicines
•low risk medicines
•Like herbal medicines, traditional medicines, vitamins, homoeopathic and
naturopathic products.
•Can be registered or listed, depending on ingredients and claims made.
13

14. LEGISLATIVE FRAMEWORK OF MEDICINES
KEY LEGISLATION ACT-
Therapeutic Goods Act 1989
Therapeutic Goods (Charges) Act 1989
•Supportive role by Therapeutic Goods Regulations, and various Orders and
Determinations.
KEY LEGISLATION FOR REGULATION-
Therapeutic Goods Regulations
Therapeutic Goods (Charges) Regulations
KEY ORDERS-
Therapeutic Goods (Groups) Order No. 1 of 1992
Therapeutic Goods (Excluded Goods) Order No. 1 of 1998
Therapeutic Goods Order No. 20, 29, 48, 56 and 63
14

15. Key Advertising and manufacturing of medicines in Australia are-
1. Therapeutic Goods Advertising Code
2. The Australian Code of Manufacturing Practice for Therapeutic Goods.
THERAPEUTIC GOODS ACT(1989)
Objective
1. To provide the establishment and maintenance of a national system of controls
relating to the quality, safety, efficacy.
1. The timely availability of therapeutic goods including medicines in Australia.
2. It sets out requirements for manufacturing, supplying, advertising and labelling of
medicines.
3. It details the requirements for listing or registering medicines in ARTG.
This act applies to all parties who supply medicines or manufacture medicines, parties
who import or export medicines.
15

16. THERAPEUTIC GOOD REGULATION
Objective-
•It prescribe matters w.r.t the manufacture, supply, advertising, registering or listing
of medicines
•Makes it necessary or convenient to carry out or give effect to the TGA.
THERAPEUTIC GOOD ADVERTISING CODE
Objective
• It ensure the conduct of marketing and advertising of medicines in a manner that
promotes the quality use of medicines.
• It is socially responsible and does not mislead or deceive consumers.
16

17. THERAPEUTIC GOODS ADMINISTRATION
TGA is a division of the Commonwealth Department of Health and Aged Care and is
responsible for administering the TGA.
STEPS IN THE OVERALL CONTROL OF SUPPLY OF MEDICINES BY THE TGA
1. pre-market evaluation and approval of medicines intended for
supply in Australia
2. licensing of manufacturers in accordance with international
standards under GMP
3.post-market monitoring, through sampling, adverse event reporting, surveillance
activities, and response to public inquiries;
4. development, maintenance and monitoring of the systems for
registering and listing of medicines; and
5. the assessment of medicines for export.
17

18. OTHER COMMITTEES INVOLVED IN
REGULATION
There are 14 such committees which participate in the regulatory framework.
Some of the committees which play an important role are-
1. The Medicines Evaluation Committee
• It is a statutory committee which provides advice to the TGA if a new
substance/medicine should be permitted on the ARTG as a L/R product.
2. Therapeutic Goods Committee
It is an expert committee which is responsible for advising the Australian
Minister for Health and Aged Care on adoption of
 therapeutic standards
requirements for labelling/packaging
 manufacturing principles.
3. Therapeutic Goods Advertising Code Council
• It is responsible for the review and maintenance of the Therapeutic Goods
Advertising Code.
18

19. PATENT OF MEDICATIONS
1. The standard patent protection for a new medicine is 20 years.
2. It can be extended by a maximum of five years.
3. The Australian government is responsible for granting patents, thus it
does not enforces patent rights.
4. Enforcement is the responsibility of the patent right holder.
19

20. REGULATION OF MEDICINES
(A) Pre-Market Assessment
Medicines must be listed or registered in the ARTG before they are supplied.
They undergo assessment before they are listed or registered.
PROCEDURES COMMON TO BOTH LISTED AND REGISTERED ARE-
1. The sponsor submits an application to the TGA for listing or registering in the ARTG.
2. The bodies which determines medicine is listable / registrable are-
• CMEC - Complementary Medicines Evaluation Committee
• MEC - Medicines Evaluation Committee
• ADEC - Australian Drug Evaluation Committee
3. The TGA evaluates/refers the application to external committee for evaluation.
4.If accepted, an AUST-L or AUST-R number will be issued.
5.If rejected, the sponsor may appeal.
• The appeal is handled by the TGA.
• The sponsor submits additional information.
• The sponsor may furthur appeal to the Secretary of Department of Health and Aged
care.
20

21. Determination of a Listable / Registrable Product
Is the product a Therapeutic Good?
(refer to Therapeutic Goods Act 1989, S.3.(1)) NoYes
Based on the substance(s) and presentation of the
formulation, are the goods Listable or Registrable?
Listable:
Those goods which meet the requirement of Schedule 4
of the Therapeutic Goods Regulations 1990
Registrable:
Those goods which are not permitted in Schedule 4 of the Therapeutic
Goods Regulations 1990, and are not exempt in Schedule 5
Based on the claims, are the goods Listable
or Registrable? To decide, please determine the
level of the claims
Register the product
HIGH
 Disease management claims
 Preventative claims
 Vitamin / mineral deficiency claims
MEDIUM
 Health enhancement claims
 Risk reduction claims
 Discrete events claims
 Aids / assists claims
 Symptom claims (when related to a disease /
disorder)
GENERAL
 Health maintenance claims (including
nutritional support)
 Vitamin / mineral supplementation claims
 Aids / assists claims
 Symptom claims (when not related to a disease
/ disorder)
 Claims for traditional syndromes / actions
Product becomes
Registrable
Claims to be evaluated by
CMEC, MEC or ADEC
Product is Listable
Product is Listable
21

22. Process of listing or registering medicines in the Australian Register of
Therapeutic Goods, through diagrams 1, 2 and 3.
Start
Here
A sponsor applies to
TGA for listing. The
product has been
assessed by the
sponsor against
defined standardsby
TGA (self-
assessment).
Application and
declaration
lodged via
Electronic
Lodgement
Facility (ELF)
Paper application
and declaration
lodged via Form
F03
Appeal provisions
apply
Application
and fee
forwarded to
BMU of
TGA. BMU
checks to
ensure
information
contained in
the
applicationis
complete.
Application
forwarded to
ARTG section
of TGA.
ARTG section
checks to
ensure all
relevant
information
has been
supplied.
NO
Post Listing Phase
(Eligibility Review)
10 working days
timeframe
File forwarded to
Australian Listed
Drugs Unit for
eligibility check to
ensure:
 Ingredients
are
permitted;
 Claims, (both
therapeutic and
advertising),are
not prohibited.
 Warning
statements are
includedwhere
necessary.
If the application passes
the eligibility check,
the sponsor receives a
confirmation letter and
the medicine is listed in
the ARTG.
BMU - Business Management Unit
ELF - Electronic Lodgement Facility
TGA - Therapeutic Goods Administration
ARTG - Australian Register of Therapeutic Goods
Certificate of
Listing
issued
to sponsor,
which
includes
AUST L
number, any
additional
information
or standards
required to
be observed.
YES
Diagram 1 - A Roadmap to Listing Medicines in the Australian Register of Therapeutic Goods
Source: Commonwealth Department of Health and Aged Care, Listed Medicines
22

23. Diagram 2 - A Roadmap to Registering Non-Prescription (Low Risk) Medicines in the
Australian Register of Therapeutic Goods
START
HERE
Application
forwarded to OTC
Medicines
EvaluationSection
of TGA
Over-The-Countermedicine
Application forwarded
to Office of
Complementary
Medicines of TGA
MECadvice
required?
YES
Medicines Evaluation Committee (MEC)
OR
Complementary Medicines Committee
(CMEC)
 Advice may be required for most new
applications and applications for some
variations
Complementarymedicine
CMEC
advice required?
YES
NO
TGA
Review
of
applica-
tion
NDPSC
advice required? NO
YES
Referred to
National Drugs
& Poisons
Schedule
Committee
(NDPSC)
TGA
decision Application
approved?
YES
Product given provisional
entry in ARTG
A provisional record of
registration and AUST R
number is sent to sponsor
Sponsor verifies record and
returns to TGA
PRODUCT
REGISTERED
NO
Appeal
provisions
apply
NO
TGA - Therapeutic Goods Administration
MEC - Medicines Evaluation Committee
NDPSC - National Drugs and Poisons Schedule Committee
OTC medicines - Over-the-counter medicines
CMEC - Complementary Medicines Committee
ARTG - Australian Register of Therapeutic Goods
Application
process by
Business
management
unit of TGA
Source: Commonwealth Department of Health and Aged Care, Non-Prescription (Low Risk) Registered Medicines23

24. Diagram 3 - A Roadmap to Registering Prescription (High Risk) Medicines in the Australian
Register of Therapeutic Goods
NO
Priority status may be
granted in order to speed up
applications, where:
 Active ingredients are
new chemical entities;
 Product is for
treatment ordiagnosis
of a serious, life
threatening, or
severely debilitating
disease orcondition;
and
 Clinical evidence
indicates that the
medicine mayprovide
an important
therapeutic gain.
Yes
START
HERE
Application forwarded
to Business
Management Unit
of TGA
Application forwarded
to Drug Safety and
Evaluation Branch
of TGA
Sponsor
requests
prioritystatus
forapplication
NO
CATEGORY 1
applications:
New medicines / Chemical
entities / New brands
Appeal
Provisions
apply
NO
Drug Safety and
Evaluation
Branch, DSEB
considers
recommendation
DSEB
approval to
register
NO
YES
PRODUCT
REGISTERED
AS A
PRESCRIPTION
MEDICINE IN
THE ARTG
Variation
approved?
CHANGES MADE TO THE
RECORD IN ARTG
REAPPLY
Evaluation
by TGA or
external
evaluators
Referred to
Australian
Drug
Evaluation
Committee,
ADEC
YES
Drug Safety and
Evaluation Branch
reviews priority status
Priority
status
approved?
YES
ADEC
recommendation for
approval or rejection
Product approved
 Product Information and relevant
Special Conditions sent to sponsor
for verification
 Sponsor verifies documentation
 Certificate of Registration issued
Referred to
Australian drug
evolution
committee, ADEC
Proceeds as normal
Category 1
application
Evaluation by
TGA or
external
evaluators
CATEGORY 2 applications:
Products already approved in
'acceptable' countries
 Sponsor provides two
evaluation reports from
acceptable countries
(Canada, USA, UK,
Sweden, Netherlands, etc.)
CATEGORY3
applications:
variations of
medicines which do
not need to include
clinical, pre-
clinical, or bio-
equivalence data.
Evaluation
by TGA
Source: Commonwealth Department of Health and Aged Care, Prescription (High Risk) Registered

25. Table 1 -
Timeframes for Processing Applications for the Entry of Non- Prescription Medicines
onto the Australian Register of Therapeutic Goods in 1999-2000
Type of application
Target time
(workingday)
Average time
(workingday)
Listed medicines
Lodged via the electronic lodgment facility
10 5.6
Listed medicines
Lodged via paper form
30 15.2
Variations of non-prescription (low risk) registered
medicines
No information
available
No information
available
New non-prescription (low risk) registered medicines 71 59.5
Source: Commonwealth Department of Health and Aged Care, Annual Report, 1999-2000.
Table 2 - Timeframes for Processing Applications for the Entry of Prescription Medicines onto the
Australian Register of Therapeutic Goods in 1999-2000
Category
Statutorytime
limit1
(workingday)
No. of applications
processed in the period
No. of applications
resolved within
time limit
1* 255 371 371
2** 175 0 Not applicable
3*** 45 831 831

26. Registration Fee Application Fee $ Evaluation Fee$
New chemical entity 39,800 159,200
Extension of indication 23,700 94,600
Major variations 15,400 61,600
New generic product 15,200 60,700
Additional trade name 2,500 10,000
Minor variation( change in
formulation , composition
,design specifications)
910 3,630
Other variation 1,300 Not applicabale
Table 3- Registration fee for application for Prescription Medicines onto the
Australian Register of Therapeutic Goods

27. Three types of applications for prescription medicines have to be
submitted to TGA
Category 1 applications:
• new medicine, new dosage form, new strengths and new generic drug products.
• After submission of Application, it will take 40 working day period for TGA to take
decision whether to accept or reject the application.
• After the acceptance of application, 255 working days is required by TGA to completely
evaluate the application.
Category 2 applications:
• For generic drug products which are already accepted in other regulated countries such as
U.S.A, Canada, Europe..etc.
• Two independent evaluation reports has to be submitted.
• TGA will take 20 working day period to take decision whether to accept or reject the
application.
• After the acceptance of application, 175 working days is required by TGA to completely
evaluate the application.
Category 3 applications:
• These are applications submitted to bring a post approval change.
• TGA will take 40 working day period to accept or reject the change.
• After the decision extra 30 working day is given to sponsor for consideration of decision
i.e. accept or rejection of change. 27

28. Registration phases for prescription drugs
Phase 1-Pre-Submission Phase:
• Applies to Category 1 & 2 applications
• Start with Pre-submission Planning Form(PPF).
• Once a PPF has been considered complete and acceptable, the TGA begins the
process of securing evaluators for the dossier.
• Contains quality, clinical, non clinical evidence included in dossier.
• PPF acceptable-A TGA Planning letter sent to applicant with expected dossier
lodgment date, and target dates.
• DSEB (drug safety evaluation board)application form 15 & sponsor application letter
sent to FSG along with the fees.
• The Planning letter is sent 15th of the month, following the month in which PPF is
processed.
• Requirements of Pre-Submission:
PPF , Module 2 data, Certificate by applicant, Application fees
28

29. Phase 2- Submission Phase
• Dossier submission is done in eCTD (electonic common techical
document)format.
• This phase starts with receipt of dossier & ends when TGA sends
applicant Notification Letter .
• Dossier must be received by TGA on 7th of month following receipt of
Planning Letter.
• Notification letter sent to the application within end of the month in
which dossier was lodged.
• Notification letter advises the applicant whether the application is
accepted or not.
• The full evaluation fees should be paid after receiving the letter,
within 2 months.
29

30. Phase 3-First round assessment phase
• dossier are evaluated during this phase.
• 1st round assessment starts with Notification letter & ends with
Milestone 3 Letter
• Applicant will be sent Milestone 3 Letter including:
i)S31 requests for information or documents required.
ii)Copies of the first round assessment reports prepared by the
quality, nonclinical, clinical and evaluators.
• 1st round evaluation requires
i)3 months for generic application
ii)4 months for other applications.
• TGA Delegate, Evaluators, DSEB can further send evaluation reports to
ADEC for advice in complicated applications
30

31. Phase 4-S31 Response Phase
• Applicant prepare a response and send the response to the TGA.
• The S31 request response phase ends on the date by which the
applicant is required to respond to the S31 as identified in the
section 31 request letter .
• Proposed S31 response time-30-60 days.
• The S31 request response period does not count within the 255
working day period for evaluation.
• The response to S31 request containing information & documents
should be in CTD format-hard & electronic copy formats.
31

32. Phase 5-2nd round assessment Phase
• Evaluators will consider the response obtained by applicant &
complete evaluation of data.
• TGA will complete the 2nd assessment report:
i) Within 2 months for generics
ii)Within 1 month for other applications.
• Applicant will be given 14 calender days after the TGA issues
the final evaluation report, in which to review & advice the
TGA of any errors occurred.
32

33. Phase-6-Expert Advisory Review Phase
• After phase 5-evaluation report is considered by delegate. The delegate may seek
advice by various committees.
• The major advisory committee are ACPM (Advisory Committee on Prescription
Medicines)
• The expert advisory review phase begins on the day of Delegate’s request to ACPM.
• The applicant is notified of the ACPM meeting & the applicant ensures that a pre-
ACPM response is received by committee 13 days before the meeting.
• Delegate sends a copy of the request to the applicant prior to the ACPM meeting to
allow the applicant to compile a Pre-ACPM response. The Pre-ACPM response is
the applicant’s opportunity to provide final comment on the application .
• The ACPM advice is published in Australian public assessment report (AusPAR)
33

34. Phase-7 Decision phase
• TGA Delegate will determine whether the application
is to be approved or not.
• The applicant will be notified in writing of the decision
within 28 days of it being made .
• The decision Phase begins when the ACPM advice is
sent to the applicant on the 15th of the month of the
ACPM meeting.
• The decision phase is completed when the applicant is
notified of the delegate’s decision 6 weeks after the
ACPM meeting.
34

35. Phase 8-Post decision Phase
• At this Phase the Administration & regulatory activities are completed.
• Post-decision phase begins when applicant is notified of the
Delegate’s decision.
• The phase is completed by the end of the month following the
delegate’s decision.
• A new Registry entry can be included on ARTG once applicant
provides Patent Certificate or notice to the TGA.
• The provisional ARTG record will become ARTG Record of
Registration.
• The applicant notifies actual commencement date of the marketing
35

36. (B)Manufacturing Requirements
• Australian manufacturers of medicines must be licensed under -
(i) Therapeutic Goods Act 1989
(ii) Processed by principles of Good Manufacturing Practice
• The aim of licensing is to protect public health by ensuring that medicines
meet definable standards of quality
Licensing of Manufacturers
• manufacturing premises are assessed through an inspection, i.e. an audit
• Auditors from the Therapeutic Goods Administration conduct audits of the
manufacturing premises and a licence is issued only after all the
requirements have been met.
• Audits are conducted at regular intervals after the licence has been granted
-- generally every 15 to 24 months, depending on the complexity of the
manufacturing process
36

37. The sequence of events in applying for a manufacturing licence is outlined below
A sponsor submits an application form and pays an application fee to the
Therapeutic Goods Administration.
The application is then checked to make sure that all information is included.
A Good Manufacturing Practice auditor from the Therapeutic Goods
Administration is appointed and a date is scheduled for an audit.
The audit is conducted using the Australian Code of Good Manufacturing
Practice for Therapeutic Goods -Medicinal Products.
The auditor lists any non-conformances noted during the audit in an audit
report together with a request to the sponsor that evidence of corrective
action shall be provided within four weeks.
The auditor completes a recommendation for the issue of a licence,
including any conditions applicable.
If the recommendation is approved by the Therapeutic Goods
Administration, a licence invoice is issued.
The licence is issued upon payment of the licence fee.
Once issued, a licence remains in force
until it is suspended, cancelled, or
revoked. 37

38. (C) Post-Market Vigilance
(1) In Australia, post-market vigilance activities include the following:
• Investigating the problems reported through the Adverse Drug Event
Reporting System.
• Inspections of the manufacturing premises to ensure that the process as per
Code of Good Manufacturing Practice
• conducting laboratory testing of products on the market
• conducting surveillance activities.
(2) Adverse Drug Event Reporting- Australia specific
• Adverse Drug Reactions Advisory Committee (ADRAC) is responsible for
monitoring drug safety in the post-marketing phase.
• Reports of ADR received by the ADRAC Secretariat where they are assessed.
• checking the report, assigning a causality rating between the adverse
reaction and the suspected drug, and making the decision for clinical or
laboratory testing and results are required, and reports are then entered
into a database and reviewed by the ADRAC
• ADRAC provide advice on the appropriate responses to adverse reactions.
38

39. (D) Regulation of Therapeutic Claims of Medicines
• Three levels of therapeutic claims - high, medium and general.
• Listed medicines are allowed to carry medium and general levels of therapeutic
claims
• Registered medicines are allowed to carry all three levels of therapeutic claims.
• There are two types of evidence which may be used to support therapeutic
claims. They are scientific evidence, and evidence based on traditional use of a
substance or a product.
• Scientific evidence refers to quantifiable data which include Human and animal
studies data and evidence of biological activity.
• Scientific evidence support all three claims.
• Evidence of traditional use refers to documentary evidence that a substance has
been used over three or more generations of recorded use for a specific health
related or medicinal purpose. This Evidence only be used general levels of
therapeutic claims.
39

40. (E) Regulation of Advertisements
• In Australia, only non-prescription (low risk) registered medicines and listed
medicines can be advertised publicly and the advertisements must comply
with the Therapeutic Goods Advertising Code.
• Prescription (high risk) registered medicines are not subject to the
Therapeutic Goods Advertising Code as it is illegal to advertise them publicly.
The approval process is outlined below: Advertisements
• Draft advertisements of non-prescription medicines are submitted to the
Australian Self-Medication Industry for approval
•
• The advertisements are reviewed. If the advertisements are approved, an
approval number will be allocated.
• Print advertisement and this approval number must appear on the
advertisement.
• Approvals are valid for a period of two years. When the approval expires, the
advertisements must be submitted again for re-approval.
40

41. (F)Regulation of Labelling
Labelling of medicines is governed by the Order (No. 48) under the
Therapeutic Goods Act 1989
Information on the labels of medicines includes: -
 Names and quantities of all active ingredients
 Name of the product
 Quantity of the product (pack size)
 Dosage form
 Batch number, expiry date and storage conditions
 An AUST R number if registered, or an AUST L number if listed
 Name and proportion of preservative used
 Name and address of the sponsor
 Relevant warning statements
 Statement of purpose of use of the medicine
41

42. (G)Control of Import
Good Manufacturing Practice for Medicines Manufactured Overseas
• If a medicine is manufactured in other country before it can be supplied to
Australia, the sponsor meet all the criteria according the therapeutic good
administration of Australia.
• Two ways are open to the sponsor to establish Good Manufacturing Practice:
(i) To provide an acceptable form of evidence
(ii) To engage the Therapeutic Goods Administration to conduct an audit
at the place of manufacture.
42