Key Strategic Directions for 2005-06
Establishment of the Trans Tasman Therapeutic Products Regulatory Scheme
In December 2005, the Therapeutic Products Interim Ministerial Council announced the deferral of the start up date for the joint Trans Tasman Therapeutic Products Regulatory Scheme. The deferral was to allow an extensive consultation program to enable industry, in particular, to review and comment on the legislation and Rules for the new regulatory scheme.
Since then, the TGA and Medsafe (the New Zealand Medicines and Medical Devices Safety Authority) have made steady progress towards the establishment of the Australia New Zealand Therapeutic Products Authority (ANZTPA) and the joint regulatory scheme. The first set of documents detailing the proposed joint regulatory scheme to be operated by the new Authority was released for public consultation on 23 May 2006.
Following the release of the consultation documents, information/consultation sessions were held by Medsafe and the TGA in New Zealand and Australia during June 2006. The meetings provided an opportunity for industry and other interested stakeholders to hear about the proposed regulatory scheme, ask questions and provide preliminary feedback. Submissions from industry, consumers and other interested stakeholders are being sought on the consultation documents, which to date include the draft Rules for medicines and medical devices.
Before the commencement of the joint regulatory scheme, stakeholder consultations need to be completed and legislation introduced and passed by the parliaments of both countries. Further details on the Stakeholder Consultation Programme 2006-07 are available from the ANZTPA web site
Agreements with International Agencies in Relation to the Regulation of Therapeutic Products, Chemicals, and Gene Technology
Memorandum of Understanding between the TGA and the Federal Department of Home Affairs acting in the name of the Federal Council of the Swiss Confederation
The TGA and the Swiss Federal Department of Home Affairs signed a Memorandum of Understanding (MoU) on therapeutic goods in Canberra on 29 March 2006.
Swissmedic (the Swiss Regulatory authority for therapeutic products) and the TGA have developed a strong relationship over the years, particularly in the manufacture of medicines through Good Manufacturing Practice (GMP) inspections and the regulation of medical devices through the Global Harmonisation Task Force and the global device vigilance exchange programs.
The MoU formalised cooperative arrangements for the exchange of information relating to the regulation of all therapeutic products, particularly in the areas of medicines’ GMP inspections and post market monitoring of therapeutic products. It also serves to facilitate and encourage the development of collaborative activities and the sharing of information relating to the regulation of medicines and medical devices.
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Australia-Canada Memorandum of Understanding on Quality Management Systems Certification for Medical Device Manufacturers
Memorandum of Understanding negotiations in 2005-06 between the Canadian Health Products and Food Branch (HPFB) and the Australian TGA on the reciprocal recognition of quality management system (QMS) certifications for medical device manufacturers entered the confidence building phase. A rigorous confidence building framework was developed that includes, but is not limited to, a review of documentation and audits of each other’s processes, procedures and systems for conducting audits of manufacturers’ quality management systems. The confidence building exercise will also include observed on-site audits of medical device manufacturers.
Due to operational considerations, both parties agreed to revise the timelines for the MoU. The confidence building phase of the project (with the exception of the observed audits), is scheduled to be completed by the end of the first quarter of 2007, after which the TGA and the HPFB expect to be able to sign the MoU and receive applications from manufacturers to participate in observed audits.
Under the MoU, QMS certifications issued by the TGA will be recognised by the HPFB and considered as part of an application for a device licence that would allow supply in Canada. Likewise, QMS certifications issued by a participating Canadian registrar will be recognised by the TGA and considered as part of an application for a Conformity Assessment Certificate issued by the TGA.
Once operational, this arrangement will avoid any duplication of QMS audits currently required for manufacturers who export their medical devices to the two jurisdictions.
Review of Access to Unapproved Therapeutic Goods
The TGA and the National Health and Medical Research Council jointly commissioned a report of the Review of Access to Unapproved Therapeutic Goods, which was completed and accepted by the Clinical Trials Review Steering Committee set up to oversee the project. This review was intended to examine the environment for clinical trial research in Australia and New Zealand and to make recommendations to improve existing systems and to advise on a new system for the Trans-Tasman environment.
The report underwent a period of public consultation until 8 July 2005. The TGA encouraged initial submissions from all stakeholders, including the community, through newspaper advertising and the TGA web site
. A Government response to the review is being finalised. The Government response to the review will guide any required changes to TGA functions prior to the establishment of ANZTPA and be reflected in the joint regulatory scheme.
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In Vitro Diagnostics Regulatory Framework
In vitro diagnostics
(IVDs) are defined as any instrument, equipment or apparatus, reagent (alone or in combination) or control/calibrator, that is intended to be used in vitro for the examination of a specimen derived from the human body.
The TGA and industry reached agreement on the proposed IVD regulatory framework and the associated cost recovery arrangements in November 2005.
The IVD regulatory framework will be implemented by the TGA in two stages, commencing with the regulatory framework for commercial IVDs, proposed for 2007. This will be followed by the regulatory framework for in-house IVDs at a date to be determined. Higher risk Class 4 commercial IVDs will have two years to meet the new requirements, while the lower risk Class 1-3 commercial IVDs will have four years to meet the new requirements.
The TGA held a round of industry seminars in early May 2006, in major capital cities, to educate stakeholders about the new requirements. The TGA is working with industry to develop guidance documents on the new regulatory system.
The new regulatory system will bring Australia into line with international best practice for the regulation of IVDs.
Cellular and Tissue Therapies
Proposed Regulatory Framework for Human Tissues and Cellular Therapies
Currently, some human cell and tissue products are subject to regulation as medicines or medical devices and others are exempted, for example whole organs and products manufactured for individual patients under the supervision of the treating medical practitioner. These arrangements will be brought together within a single office for biologicals under ANZTPA. This office will focus in particular on the transmission of infectious diseases associated with the use of human cells and tissues as therapeutic products. This approach for the regulation of products derived from humans and other biological sources is similar to developments for regulation of biological products in other countries.
During 2005-06, the TGA continued consultations with stakeholder groups on specific issues requiring development to underpin the regulatory framework for human tissues and cellular therapies. Jurisdictional input to the framework and its proposed options for funding arrangements has been a significant milestone in drawing together critical elements of the proposal.
It is proposed that the regulations will be implemented in 2007 and will keep Australia consistent with international best practice.
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Gene Technology Regulation
During 2005-06, the Gene Technology Ministerial Council (GTMC) appointed an independent panel to conduct a review of the Gene Technology Act 2000
in accordance with Section 194 of the Act. The Department’s Acute Care Division provided the independent panel with secretariat support. The panel’s report was tabled in the Australian Parliament on 27 April 2006 and Australian, State and Territory government ministers commenced the preparation of a response by all jurisdictions.
Following extensive consultation on proposed technical amendments to the Gene Technology Regulations 2001 with a wide range of interest groups and the public, the Gene Technology Amendment Regulations 2005 are being finalised by the Office of the Gene Technology Regulator (OGTR) in conjunction with the Office of Legislative Drafting for consideration by the GTMC.
The OGTR is liaising with the Plant Biosafety Office of the Canadian Food Inspection Agency to establish an officer exchange arrangement to work on areas of mutual regulatory interest.
The risk assessment and risk management plans for all licence applications to deal with genetically modified organisms processed by the OGTR in 2005-06 were prepared in accordance with the Regulator’s revised Risk Analysis Framework
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The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) worked closely with the TGA and industry in 2005-06 to address complex boundary issues between areas of regulation in regards to the supply of cosmetics. This involved clearly defining what is regulated as therapeutic goods and what is regulated under cosmetics legislation. The joint collaboration resulted in the establishment of a new regulatory framework for the supply of cosmetics, which was endorsed by the Australian Government in November 2005.
In 2005-06, NICNAS also established framework controls for chemicals that present low regulatory concern. This resulted in the introduction of special permit categories, which include chemicals produced for export only purposes.