TGOs versus Pharmacopoeias

Do I have a choice?

Jenny BurnettDirector, Scientific Operations ManagementScientific Evaluation Branch Therapeutic Goods Administration

RACI Pharmaceutical Science Group Seminar10 August 2015

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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

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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)

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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

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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’

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How do we measure quality?

- is there more to life than the BP??

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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???

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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

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Ministerial DeterminationsSection 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 2011Certain vaccines and ‘immune globulins’ (USP)

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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’

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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

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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

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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