Pharmacopoeial standards for medicines in the Australia New Zealand therapeutic products agency
Consultation
5 September 2005
- This consultation closed on 14 October 2005.
The information on this page relates to the following consultation paper
Background
With the proposed formation of the Australia - New Zealand agency for the regulation of therapeutic products, to commence operation by 1 July 2006, the responsible Ministers agreed that the setting of harmonized standards for therapeutic products was crucial to the success of the joint Agency. It was further decided that an expert committee, the Joint Interim Expert Advisory Committee on Standards (JIEACS), comprising members from both countries and having a variety of relevant backgrounds, be established to develop and make recommendations on standards.
The JIEACS met on 7 June 2005 and was briefed on the current situation relating to standards for therapeutic products in Australia and New Zealand. The Committee developed a workplan that directed detailed consideration of the default pharmacopoeial standard(s) for the Agency to a specialist subcommittee. The Pharmacopoeial Standards Subcommittee met on 11 July 2005. The consultation paper was drafted and revised by the Subcommittee and revised and approved by the JIEACS.
This stakeholder consultation is being undertaken to assist in deciding what should be the default pharmacopoeial standard(s) for the new Agency noting that different approaches to pharmacopoeial standards are followed by the Therapeutic Goods Administration in Australia and by Medsafe in New Zealand.
The membership of the JIEACS is available on this website.
Call for comment
Comment from stakeholders was invited on the document Pharmacopoeial Standards for Medicines in the Joint Australia New Zealand Therapeutic Products Agency.
Medsafe and the TGA encouraged all stakeholders to review the options in the consultation paper. It is intended that the legislative arrangements that create the Agency will include the definition of the default pharmacopoeial standard(s) that form the basis of the legally binding standard(s) for medicines that seek a product license from the Agency.
Comments received in response to this consultation process will be considered by the JIEACS, which will then formulate its recommendation(s) to the Ministerial Council on the requirements for pharmacopoeial standard(s) to be applied by the Agency. It is anticipated that the standard(s) would become effective from the commencement date of the Agency, with a transition period of up to three years for licence holders to comply with the regulatory changes associated with the start up of the Agency.
Questions relating to submissions
Any questions relating to submissions should be directed to the Project Officer, by email at standards@jtaproject.com.
Consultation paper
This report is available in pdf and rich text format.