Consultation: Remaking of TGO No. 77 – Microbiological Standards for Medicines
This consultation closes on 6 March 2018.
Invitation to comment
The TGA is seeking comments from interested parties on a proposal to remake Therapeutic Goods Order No. 77 – Microbiological Standards for Medicines (TGO 77) without technical amendment.
The 'Guidance on Therapeutic Goods Order No.77 Microbiological standards for medicines', dated 12 September 2008, provides a plain English explanation of the various requirements of the Order and their application, thereby assisting sponsors to achieve compliance. It does not form part of the Order but will be updated when the Order is remade.
- TGO 77 - Legislative Instrument - F2008L03574
- TGO 77 - Explanatory Statement - F2008L03574ES
- TGO 77 - Guidance document
Document released for consultation on Tuesday 6 February 2018.
Interested parties should respond by close of business Tuesday 6 March 2018.
Feedback will be released following consideration of submissions. (See 'What will happen').
About the consultation
The requirements of TGO 77 apply to a medicine that comes within the operation of Part 3-1 of the Therapeutic Goods Act 1989 (‘the Act’), which provides for the application of standards to therapeutic goods. TGO 77 specifies the minimum microbiological requirements with which a medicine must comply throughout its shelf life. It specifies 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 non-sterile medicines.
TGO 77 has been in force since 1 January 2010. It continues to operate effectively and efficiently. In accordance with the Legislative Instruments Act 2003, legislative instruments are automatically repealed after a fixed period of time (subject to some exceptions). This automatic repeal is called sunsetting. TGO 77 is due to sunset on 1 October 2018.
Accordingly, we are proposing to remake a new Order under subsection 10(1) of the Act to specify the minimum microbiological requirements with which a medicine must comply throughout its shelf life. The new Order will reflect the current requirements of TGO 77 without technical amendment; it is not intended to substantially alter existing arrangements. The new Order is needed to provide continuing clarity on the requirements for microbiological quality of medicines following the automatic repeal of TGO 77. As with TGO 77, the new Order will be consistent with internationally harmonised standards where such standards exist.
Stakeholders who encounter difficulties complying with the requirements for a specific medicine can apply to the TGA for consent for non-compliance to the applicable standard. Such applications for consent are considered on a case-by-case basis.
The development of TGO 77 followed from work undertaken by an expert committee in preparation for the proposed joint Australia New Zealand regulatory agency. Stakeholder consultation was conducted on the technical requirements that should be included in an Order on microbiological standards for the proposed joint regulatory agency. Following the cessation of efforts to establish the joint regulatory agency, the Therapeutic Goods Committee (TGC) recommended that the draft joint agency Order be converted to a form suitable for adoption under existing Australian legislation and undergo stakeholder consultation.
Comprehensive stakeholder consultation was undertaken on a draft of TGO 77 in early 2008. Peak industry bodies, consumer organisations, health professional organisations and relevant areas of government were invited to provide comments. The comment period was approximately 6 weeks.
The consultation attracted 26 submissions, all of which were considered by the TGC at its 32nd meeting, held on 29 April 2008. In general, stakeholders were supportive of the proposed TGO 77. Some submissions argued against the microbiological requirements proposed for some complementary medicine dosage forms, in particular, herbal teas (see Schedule 2 of TGO 77). The TGC noted that there was no internationally agreed microbiological standard for such products and that the TGA anticipated that existing medicines would readily comply with the requirement.
Following consideration of stakeholder responses, the TGC advised that draft TGO 77, as amended by the committee at that meeting, should be adopted as a standard for medicines made under section 10 of the Act. TGO 77 came into effect on 1 January 2010.
Content of submissions
Submissions must be relevant to the proposal to remake TGO 77 and to update the guidance document when the Order is remade. Submissions must be received by the closing date.
In addition, submissions may include information on:
- The suitability of the test requirements and limits specified in TGO 77.
- Suggested improvements.
- Whether or not you support the proposal. If you do not support the proposal, you may make suggestions for an alternative acceptable to you.
- An assessment of how the proposal will impact on you.
How to submit
All submissions should be accompanied by a TGA submission coversheet. Submissions must include full personal or organisational contact details (including address, telephone number and email).
Electronic submissions are preferred. Complete the online Consultation submission form, upload your submission in either pdf or word format and click submit.
Alternatively, hardcopy submissions with a printed coversheet (see link below) may be mailed to:
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Any questions relating to submissions should be directed to the Microbiology Section by email to TGA .Laboratories@health.gov.au or by telephone to 02 62328921. Please include ‘Proposal to remake TGO 77’ in the subject line of the email.
What will happen
All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).
Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.
- The TGA collects your personal information in this submission in order to:
- contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
- help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
- Seek feedback about how the consultation was undertaken.
- Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
- More information on consultations and privacy is included in the submission form and on our website.
- In response to the Expert Review of Medicines and Medical Devices Regulation (the MMDR), the number of TGA advisory committees was reduced from eleven to seven. The TGC was abolished; however, its core role of advising and making recommendations about standards for therapeutic goods is preserved across the relevant new or continuing committees.