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TGA presentation given at the RACI Pharmaceutical Science Group Seminar, 10 August 2015

TGOs versus Pharmacopoeias. Do I have a choice?

11 August 2015


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  • Presented by: Jenny Burnett, Director, Scientific Operations Management, Scientific Evaluation Branch, Therapeutic Goods Administration
  • Presented at: RACI Pharmaceutical Science Group Seminar, 10 August 2015
  • Presentation summary: This presentation is an overview of TGOs versus pharmacopoeias and how these are incorporated into the Australian legislation.


TGOs versus Pharmacopoeias - Do I have a choice?

Jenny Burnett
Scientific Operations Management
Scientific Evaluation Branch
Therapeutic Goods Administration

RACI Pharmaceutical Science Group Seminar, 10 August 2015

Slide 1 - 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

Slide 2 - 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)

Slide 3 - 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

Slide 4 - 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'

Slide 5 - How do we measure quality?

  • is there more to life than the BP??

Slide 6 - 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???

Slide 7 - Default standards

  • Automatic adoption of new versions
  • Responsibility for compliance with revised monographs - stay up to date!
  • Multiple default standards may exist for the same goods

Slide 8 - 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)

Slide 9 - 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'

Slide 10 - 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

Slide 11 - 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

Slide 11 - What is out there?

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