International visitors & training

Over the past few months, the TGA has hosted a number of short-term visits by delegations from regulatory agencies in Vietnam, Thailand, Canada and Indonesia.

The TGA also provided training programs on a cost recovery basis or with financial sponsorship from AusAID in the areas of the regulation of blood and blood products (safety and quality control) and vaccine quality control for government officials from Indonesia, PNG, Fiji, Samoa, Solomon Islands, Tonga and Thailand.

In May/June 2005, the TGA Laboratories conducted a three week training course on Vaccine Quality Assurance for a senior officer from the Thai FDA. The course provided practical training in testing and evaluation of viral and bacterial vaccines.

International cooperation - Canada

The TGA is negotiating a Memorandum of Understanding (MOU) with Health Canada on Quality Management Systems Certification (QMS) for manufacturers of medical devices.

The objective of the MOU is to have an arrangement in place whereby Australian and New Zealand manufacturers of medical devices can export their products to Canada and Canadian manufacturers of medical devices can export their products to Australia and New Zealand without needing to undergo duplicate assessments of their QMS.

Products imported into Australia, under the MOU, will be assessed by the TGA for compliance against the relevant essential principles of safety and performance before inclusion on the Australian Register of Therapeutic Goods. Products exported to Canada under the MOU will still be assessed by Health Canada for compliance with Canadian safety and effectiveness requirements before being issued with a product licence.

International cooperation - EC/EFTA MRA

The TGA is awaiting advice from the European Commission regarding finalisation of amendments to the medical devices Sectoral Annex relating to a confidence building program for high risk devices and the establishment of a joint sectoral survey to monitor the operation of the agreement.

International cooperation - Malaysia

The TGA is negotiating a Memorandum of Intention of Cooperation (MOI) with the Malaysian Ministry of Health to assist Malaysia in its move to develop an internationally harmonised regulatory scheme based on the Global Harmonization Task Force principles.

International cooperation - Switzerland

The TGA is negotiating an MOU for therapeutic products with Swissmedic, the Swiss agency for therapeutic products. The objective of this MOU is to formalise an exchange of information and cooperation, particularly around regulatory decisions and post market activities.

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International meetings - APEC Seminar

Two officers from the TGA participated as trainers at the Asia Pacific Economic Cooperation (APEC) funded seminar on Global Harmonization Task Force guidance documents for medical device regulation, in Bangkok, Thailand, in June 2005. APEC is the regional vehicle for promoting open trade and practical economic cooperation among Asia-Pacific economies.

International meetings - GHTF Steering Committee

The Global Harmonization Task Force (GHTF) Steering Committee met in Brussels in May 2005 to finalise the review of GHTF procedural documents and a number of guidance documents on basic regulatory practices. These documents, which can be adopted/implemented by regulatory authorities, will be posted on the GHTF website <http://www.ghtf.org> in the near future.

International meetings - GHTF SG2 (Medical Devices Vigilance)

GHTF Study Group 2, chaired by Dr Jorge Garcia, TGA, and 11 other representatives from industry and regulatory bodies met in Milwaukee, Wisconsin, USA, from 1-3 June 2005. In addition, a special meeting was held on 31 May 2005 to revise GHTF SG2 N54 guidance document.

The key agenda items were as follows.

• Revision on GHTF SG2 N54 - consolidated global guidance on adverse event reporting.
• Discussion of the decisions made by the GHTF Steering Committee at their last meeting.
• Revision of GHTF SG2 N80 - map of SG2 guidance.
• Discussion of GHTF SG2 N79 - updating and combining GHTF SG2 N20 and N9 - guidance relating to the National Competent Authority Reporting (NCAR) program.
• Discussion of GHTF SG2 N73 - update on implementation of GHTF SG2 guidance documents.
• Discussion of the strategy for implementation of GHTF SG2 N38 - application requirements for joining the NCAR program.
• GHTF SG2 N87 (NWI N72) - standard for electronic reporting of adverse events.
• Discussion on the APEC meeting for medical device manufactures and NCAs - Bangkok June 2005.
• Discussion of GHTF SG2 N57 - content of field safety corrective action notices.
• Discussion of developments regarding ISO19218 and the nomenclature being developed by the NCI on behalf of the FDA.
• Discussion of revisions made to GHTF SG2 N12 - Précis.

A more detailed summary of the meeting is available on the GHTF website <http://www.ghtf.org>.

Other available summaries of GHTF SG2 meetings <http://www.ghtf.org/sg2/sg2-pastmtg.html> are also on the GHTF website.

International meetings - GHTF SG 5 (Medical Device Clinical Evidence)

GHTF Study Group 5, chaired by Dr Graeme Harris, TGA Chief Clinical Advisor for medical devices, held its first meeting in Canberra in January 2005 and will be focusing on harmonising clinical definitions, guidance on how to conduct and document clinical evaluations and the content and format for clinical investigation reports.

The second meeting was held in London in May 2005. Work has commenced on the harmonised definitions and guidance on clinical evaluations, as well as the development of an MOU between SG5 and ISO TC210. An MOU will avoid duplication of work relating to clinical investigations and will facilitate the utilisation of the expertise of both parties.

More detailed summaries of the meetings <http://www.ghtf.org/sg5/sg5-pastmtg.html> are available on the GHTF website.

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International meetings - ISO/TC 198 Sterilization of health care products

Vivienne Christ, Robyn Isaacson, Karen Longstaff and Kate Rusbridge of the TGA Laboratories Branch, representing Standards Australia, attended the 16th meeting of ISO/TC 198 Sterilization of health care products that was held at Standards Australia in Sydney in April 2005. ISO/TC 198, comprising 14 Working Groups, considers standards for moist heat, radiation, ethylene oxide and dry heat sterilization, biological and chemical indicators, packaging of sterile products, microbiological methods associated with products that are to be or have been subject to a sterilization process, liquid chemical sterilization, aseptic processing, washer-disinfectors as well as ensuring that terminology used throughout all the documents published by the Technical Committee is consistent.

At the meeting joint revisions of International (ISO) and European (CEN) Standards for the development, validation and routine control of sterilization processes that began in 1999 (see TGA News, Issue 31, January 2000) made significant progress.

Outcomes included:

• The progression of ISO/EN 17665 (moist heat sterilization - consolidation of ISO 11134, ISO 13683, EN 554) and ISO/EN 11137 Parts 1,2 3 (radiation sterilization - consolidation of ISO 11137 and EN 552) standards to ballot as Final Draft International Standards (FDIS).
• Due to substantial changes, ISO 11135/EN (ethylene oxide sterilization - consolidation of ISO 11135 and EN 550) is to be submitted for a second vote as a Draft International Standard (DIS). The ballot period is to be abbreviated with an expectation that provided the second DIS ballot results in approval, a ballot for FDIS can be progressed to align with the other process standards.
• It is hoped that the three main process standards may be published in late 2005 or early 2006.
• The Working Groups for moist heat and ethylene oxide sterilization are to develop technical specifications to address additional guidance identified as necessary to assist users in meeting and interpreting the requirements of the standards in industrial and healthcare settings.
• A new Working Group has been formed to develop a standard for dry heat sterilization. A working document (ISO/WD 20857) has been prepared and is to be circulated for ballot as a committee draft.

Other standards which were considered at the meeting and recommended for ballot as harmonised ISO/EN FDISs were those for biological and chemical indicators, packaging, microbiological methods - determination of bioburden and standards for clean-in-place and isolator systems used in aseptic processing. Standards for washer disinfectors (thermal disinfection) have also been recommended as FDISs. DISs for sterilization-in-place and lyophilisation associated with aseptic processing have been circulated for comment and should be circulated for ballot as FDISs by the end of 2005. A standard for washer-disinfectors using chemical disinfection for thermo-labile endoscopes has been submitted for ballot as a DIS and a Technical Specification for test soils and methods for demonstrating cleaning efficacy in washer-disinfectors is in preparation.

Of particular interest to Australian manufacturers who use radiation to sterilise their products is the incorporation of the original VD_max method published by Kowalski and Tallentire¹ into part 2 of ISO/EN 11137. This method describes the requirements for substantiation of 25 kGy as a sterilization dose. This part of ISO 11137 also provides guidance on the substantiation of 15 kGy as a sterilization dose for those products with a low and consistent bioburden which may be susceptible to higher doses of radiation.

ISO/TC 198 has proposed a transition period for the implementation of the revised standards. It is anticipated that these standards will be adopted as Australian Standards when they are published and the transition period will be advised once this process has occurred.

1. Kowalski, J.B., Tallentire, A. Substantiation of 25kGy as a sterilization dose: a rational approach to establishing verification dose. Radiation Physics and Chemistry 1999; 54:55-64.

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