Adoption of Therapeutic Goods Order No. 77 – Microbiological standards for medicines under the Therapeutic Goods Act 1989
Stakeholder consultation
25 January 2008
This consultation closed on 7 March 2008.
Background
The microbiological quality of medicines is currently regulated in Australia by sterility requirements in the British Pharmacopoeia (BP), recommendations in the BP on preservative efficacy and microbial attributes of non-sterile medicines, and the TGA Laboratories' guidelines for assessing the results of microbiological tests on non-sterile pharmaceuticals for human use <http://www.tga.gov.au/docs/html/unsteril.htm>.
Public consultation on Microbiological standards for medicines in the Australia New Zealand Therapeutic Products Authority (ANZTPA) <http://www.anztpa.org/consult/microbiological.htm> was undertaken in September 2006.
Proposal
The Therapeutic Goods Committee (TGC) has recommended <http://www.tga.gov.au/docs/html/tgc/tgc31.htm> that a new Therapeutic Goods Order to specify microbiological standards for medicines be established. The TGC has also recommended that the new Order should be based on the ANZTPA proposals and, as far as is consistent with existing therapeutic goods legislation, the new Order should include the same technical requirements and be applicable to the same medicines as identified as part of the ANZTPA process.
It is proposed that Therapeutic Goods Order No. 77 Microbiological standards for medicines (TGO 77) will be adopted as a standard made under section 10 of the Therapeutic Goods Act 1989.
Rather than incorporate Supplementary Notes, it is proposed that TGO 77 would be accompanied by a guidance document providing explanatory information and a series of questions and answers relating to the practical application of the Order.
Drafts of TGO 77 and the accompanying guidance document are now available for review by stakeholders.
Consultation
Stakeholders are invited to provide comment on Therapeutic Goods Order No. 77 Microbiological standards for medicines (TGO 77) (draft) and its companion document Guidance on Therapeutic Goods Order No 77 Microbiological standards for medicines, also in draft.
Information that would assist in the assessment of the regulatory impact of the proposal to adopt TGO 77 is also being sought as part of this consultation process.
While comments on all aspects of the new Order are welcome, the following two matters should be noted in particular.
The first of these matters relates to the work on international harmonisation between the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopoeia for general chapters relating to sterility testing, bacterial endotoxin testing, and microbiological attributes of medicines other than complementary medicines. Stakeholders should note that the BP follows the European Pharmacopoeia. Stakeholders should also note that, notwithstanding the proposal under the ANZTPA to broaden the definition of the default standard for medicines, current therapeutic goods legislation does not permit the option of multiple default standards.
The second of these matters relates to the commencement date. The date proposed for all medicines to comply with the new Order would be approximately 12 months after the new Order is signed and registered as a legislative instrument.
Comments received in response to this consultation will be referred to the TGC for consideration.
Consultation documents
Draft Therapeutic Goods Order No. 77 Microbiological standards for medicines (TGO 77) (pdf,80kb)