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Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

12 December 2018

Therapeutic Goods Order No. 77 Microbiological standards for medicines (TGO 77) was automatically repealed (sunsetted) on 1 October 2018 in accordance with the Legislation Act 2003. A new instrument, Therapeutic Goods Order Microbiological standards for medicines (2018) (TGO 98), succeeded TGO 77 on this date to provide continuing clarity on the requirements for microbiological quality of medicines. TGO 98 and its explanatory statement were registered on the Federal Register of Legislation on 14 September 2018 and reflected the requirements of TGO 77 without regulatory change. For further information refer to: TGO 98 Microbiological Standards for Medicines (2018)

In its Monitor 12 of 2018 report The Senate Standing Committee on Regulations and Ordinances indicated that:

  1. i. the explanatory statement to TGO 98 should be amended to include more information about the nature of the consultation that was undertaken in relation to the instrument; and
  2. to promote clarity for users of TGO 98, the instrument or its explanatory statement should explain more clearly how the default standards, i.e. the British Pharmacopoeia, European Pharmacopoeia and United States Pharmacopeia-National Formulary are to be adopted, i.e. whether as in force from time to time (which allows any future amendment or version of the document to be automatically incorporated) or as at a particular time.

With regard to ii) above, the intention was to adopt the default standards 'as in force from time to time'. This is permitted under subsection 10(4) of the Therapeutic Goods Act 1989, a recent addition to the Act, which commenced on 22 September 2018. However, TGO 98 was made on 12 September 2018 and registered on 14 September 2018, i.e. shortly before there was legal authority to adopt documents as in force from time to time under subsection 10(4).

For this reason it has been necessary to remake TGO 98 with a new instrument, TGO 100, incorporating those pharmacopeia 'as in force from time to time as permitted under subsection 10(4) of the Act'. The TGA undertook consultation in relation to the remaking of TGO 98 as TGO 100 with the proposed adoption of each of the British Pharmacopoeia, European Pharmacopoeia and United States Pharmacopeia-National Formulary 'as in force from time to time'. Each of the eight respondents (industry representative bodies, regulatory consultants, product manufacturers and sponsors) who provided feedback as part of the earlier consultation on TGO 77 were contacted directly, as were two industry representative bodies which had not responded to the original proposal to remake TGO 77. Seven responses were received. All were supportive of the proposal to remake TGO 98 as TGO 100 with adoption of each of the British Pharmacopoeia, European Pharmacopoeia and United States Pharmacopeia-National Formulary 'as in force from time to time'.

TGO 100 and its explanatory statement were registered on the Federal Register of Legislation on 7 December 2018 (F2018L01685) and reflect the requirements of TGO 98 without regulatory change: Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018. TGO 100 came into effect on 8 December 2018, repealing and replacing TGO 98 on this date. Its explanatory statement explains the adoption of default standards ‘as in force from time to time’ and the basis for being able to do so. As with TGO 98, it specifies the minimum microbiological requirements with which a medicine must comply throughout its shelf life, i.e. which medicines must comply with a Test for Sterility and Bacterial Endotoxin testing; which medicines must comply with a preservative efficacy test; and the acceptance criteria for microbiological quality that apply to nonsterile medicines. Like TG0s 77 and 98, TGO 100 is consistent with applicable internationally harmonised standards (where such standards exist).

A guidance document to TGO 100 will be prepared. It is expected to be available on the TGA website by late February.

Responses to the submissions to the remaking of TGO 77 and TGO 98 are being prepared and will be forwarded to the respondents. A summary of the responses will be posted to the TGA website.

Questions relating to TGO 100 should be directed to the Microbiology Section by email to TGA.Laboratories@health.gov.au or by telephone to 02 62328921. Please include 'TGO 100' in the subject line of the email.