TGOs versus Pharmacopoeias Do I have a choice? Jenny Burnett - PowerPoint PPT Presentation

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