Joint Interim Expert Advisory Committee on Standards
Meetings of the Joint Interim Expert Advisory Committee on Standards
3rd meeting of the Joint Interim Expert Advisory Committee on Standards
The third meeting of the Committee was held on 15 March 2007. Taking into consideration the advice of its Subcommittee, the Committee made recommendations to the TGA and Medsafe on the microbiological standard for medicines that should be applied by the ANZTPA. The Committee recommended only one significant departure from the proposals in the Consultation Paper. This related to the limits for "herbal teas", for which the total aerobic microbial count limit would be "not more than 107 CFU/g" and the total yeast and mould count limit would be "not more than 105 CFU/g".
The Committee had previously recommended stakeholder consultation on child-resistant packaging requirements. Taking into consideration the advice of Australia's Therapeutic Goods Committee, the Committee made recommendations to the TGA and Medsafe on the child-resistant packaging requirements for medicines that should be applied by the ANZTPA.
Packaging requirements in Australia's SUSDP for Schedule 5 and 6 medicines need to be moved into a separate standard to allow application in both Australia and New Zealand. The Committee considered a working draft of the proposed standard and recommended that further development work include public consultation.
2nd meeting of the Joint Interim Expert Advisory Committee on Standards
The second meeting of the Committee was held on 1 March 2006. Taking into consideration the advice of its sub-committee, the Committee formulated its advice on the default standard for medicines that should be specified in the Medicines Rule governing the new Agency. This advice will be incorporated into the Medicines Rule which will be subject to public consultation (see Stakeholder consultation programme 2006/07).
The Committee requested the sub-committee to continue work on general requirements for tablets and capsules. Responding to stakeholder comment from the consultation on the default standard, the Committee also requested the sub-committee to consider requirements for microbiological standards for medicines. These issues will be discussed at the next meeting of the pharmacopoeial sub-committee to be held on 11 April 2006.
The Committee had previously identified that child-resistant packaging was an area with different approaches in Australia and New Zealand. The Committee recommended that proposals in this area, and an explanatory document, be released for stakeholder consultation. Accordingly, consultation documents have now been released (see Child-resistant packaging requirements for therapeutic goods – Consultation papers).
1st meeting of the Joint Interim Expert Advisory Committee on Standards
As part of the formation of the Joint Agency, the Therapeutic Products Interim Ministerial Council established a committee of experts to make recommendations on standards to be applied to therapeutic products.
The first meeting of the core members of this committee was held on 7 June 2005 in Sydney. The committee was briefed on the establishment processes for the joint agency and on the current situation relating to standards for therapeutic products in Australia and New Zealand.
The committee discussed a range of issues relating to standards and agreed on the priorities for further actions. A workplan was developed that involves specialist subcommittees to address key issues such as the default standard to be applied to medicines under the new agency.
Meetings of sub-committees of the Joint Interim Expert Advisory Committee on Standards
4th meeting of the pharmacopoeial subcommittee of the Joint Interim Expert Advisory Committee on Standards
The fourth meeting of the Subcommittee was held on 15 March 2007. The Subcommittee gave careful attention to the stakeholder responses to the consultation paper on microbiological standards for medicines in formulating its advice to the JIEACS.
The Subcommittee also considered revised proposals on general requirements for tablets and capsules and recommended that the TGA and Medsafe release the document for public consultation.
3rd meeting of the pharmacopoeial subcommittee of the Joint Interim Expert Advisory Committee on Standards
The third meeting of the Subcommittee was held on 11 April 2006. Having identified inconsistencies between the pharmacopoeias regarding preservative efficacy standards and microbial attributes of non-sterile medicines, the Subcommittee made certain proposals regarding these matters and requested the TGA and Medsafe to undertake stakeholder consultation. The consultation paper on Microbiological standards for medicines was subsequently released.
The Subcommittee also considered certain proposals on general requirements for tablets and capsules and requested that consultation be undertaken.
2nd meeting of the pharmacopoeial sub-committee of the Joint Interim Expert Advisory Committee on Standards
The second meeting of the sub-committee was held on 17 November 2005 to consider the default standard for medicines for the new agency. This followed the closure of the consultation period on the paper Pharmacopoeial Standards for Medicines in the Australia New Zealand Therapeutic Products Agency (September 2005). The sub-committee gave careful attention to each of the stakeholder responses to the consultation paper in formulating its advice to the Joint Interim Expert Advisory Committee on Standards. The sub-committee also gave preliminary consideration to the issue of whether the new Agency required additional requirements for tablets and capsules.
1st meeting of the sub-committee to consider the default standard for the new agency
The first meeting of the sub-committee to consider the default standard for the new agency met on 11 July 2005. This sub-committee is comprised of members who are part of the core membership of the Joint Interim Expert Advisory Committee on Standards as well as associate members of this committee with specific experience in the formulation and operation of quality standards for medicinal products. The membership of the sub-committee is:
Professor Stella O'Donnell (Aus, Chair)
Professor Ian Tucker (NZ)
Dr Chris Litten (NZ)
Mr Michael Kimber (Aus)
Dr Mark Bowden (Aus)
Mr David Clayton (Aus)
Mr David Edmonds (Aus)
Mr Robert Herrington (Aus)
Mr Michael Gepp (Aus)
Mr Rob Shaw (NZ)
The sub-committee will be supported by regulatory advisers from Medsafe and the TGA.