TGOs versus Pharmacopoeias: Do I have a choice?

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This presentation is an overview of TGOs versus pharmacopoeias and how these are incorporated into the Australian legislation.

Health & Medicine

TGOs versus Pharmacopoeias
Do I have a choice?
Jenny Burnett
Director, Scientific Operations Management
Scientific Evaluation Branch
Therapeutic Goods Administration
RACI Pharmaceutical Science Group Seminar
10 August 2015

Outline
Why we have TGOs and pharmacopoeias
How these are incorporated in the Australian legislation
When these standards are applied
Where you can find information on these requirements
1

Quality is important
• Australian legislation for a system of
controls relating to safety, quality and
efficacy
– Therapeutic Goods Act 1989
• Therapeutic Goods Administration
administers the Act (and supporting
legislation)
2

TGA’s role as regulator
• Ensure quality, safety, efficacy and timely availability
• ‘Quality’ is reviewed:
- pre-market assessment
- Good Manufacturing Practice requirements
- post-market review
- testing
• Legislative responsibilities for both TGA and sponsors
3

Legislative requirements
• Section 14 and 14A of the Act
- penalties for importing, supplying, exporting goods that do not comply with
standards
• Section 25 of the Act
- ‘… must evaluate having regard to … whether the goods conform to any
standard applicable to the goods’
• Section 26 of the Act
- ‘… not to refuse to list … except where … the goods do not conform to a
standard applicable to the goods’
• Section 26A of the Act
- ‘… applicant must certify that … the medicine conforms to every standard
applicable to the medicine’
4

How do we measure quality?
- is there more to life than the BP??
5

Australian Legislation - Standards
Section 3 of the Act
A standard means any of the following
• a standard specified under section 10 of the Act
• statements in a monograph in the British Pharmacopoeia
• statements in a monograph in the European Pharmacopoeia
• statements in a monograph in the United States Pharmacopeia – National
Formulary
But which one???
6

Default standards
• BP/EP/USP
• Automatic adoption of new versions
• Responsibility for compliance with revised monographs – stay up to date!
• Multiple default standards may exist for the same goods
7

Ministerial Determinations
Section 3C of the Act
provides the power to exempt
• monographs in the BP/EP/USP
• statements in the BP/EP/USP
from being standards under section 3
For example,
Therapeutic Goods (exempting monographs of pharmacopoeias) Determination
No. 1 of 2011
Certain vaccines and ‘immune globulins’ (USP)
8

Ministerial standards
Section 10 of the Act
• Power for the Minister to make an order – legislative instrument
• An order can be
– related to quality/quantity/manufacture/labelling and packaging/testing
requirements
– a monograph in either the BP/EP/USP
– a modified monograph
– a standard published by Standards Australia
– ‘such other matters as the minister thinks fit’
9

So, can I choose?
Section 13 of the Act
an applicable Ministerial standard
+
a default standard
then
the default standard is disregarded
where they are inconsistent
10

Creation of TGOs
• Can specify a new Order even if there is an applicable default standard
• Must consult the Therapeutic Goods Committee
• Registered on the Federal Register of Legislative Instruments
• Available on the Comlaw website
www.comlaw.gov.au
11

What is out there?
• https://www.tga.gov.au/legislation-legislative-instruments
• https://www.tga.gov.au/pharmacopoeias
• https://www.tga.gov.au/therapeutic-goods-orders
• TGO 77 – microbiological
• TGO 80 – child resistant closures
• TGO 81 – blood and blood components
• TGO 89 – water for injection
12

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