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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?
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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?
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
- 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?