4th meeting of the GHTF Steering Committee

The TGA is represented on the GHTF Steering Committee by Mr Terry Slater and Ms Rita Maclachlan (Director - Conformity Assessment Branch and GHTF Chair).

The Steering Committee convened its 4th meeting on 12-13 May 2002, in Singapore, as part of the 9th GHTF Conference. The major issues considered were:

• Updates from the Global Medical Devices Nomenclature (GMDN) Maintenance Agency Policy Group
• Further development of the GHTF Strategic Plan (2002-2007)
• Approval of two Study Group documents (one each from SG2 and SG4) as "final" GHTF Guidance Documents
• Progress by the Regional Harmonization Groups of Asia and Latin America
• The provision of GHTF training activities
• The possible establishment of a permanent secretariat
• A timetable for future GHTF Meetings.

As consistently reported over the past 18 months, one of the Committee's main tasks has been to undertake a thorough and comprehensive strategic review of the GHTF.

Six key themes were identified and further refined, and a number of goals and actions have now been formulated as the core of the Plan. The Committee has now progressed a Strategic Directions document to a "near-final" draft and the Vice Chair, Mr Brian Vale, presented this during the GHTF Plenary.

The presentation highlighted the new GHTF Vision Statement, "enhancing the health of the public worldwide and facilitating innovation by harmonising the global regulatory environment". The document will form the basis of the final GHTF Strategic Plan following further refinement.

Further details may be obtained from the Steering Committee "post-meeting statement" which is now available on the GHTF website <http://www.ghtf.org>. The Meeting's Minutes will also be posted on the website within the next two months.

9th conference of the Global Harmonization Task Force

"The Global Medical Device Regulatory Model: From Development to Implementation"

Australia, represented by the TGA, is the current Chair of the Global Harmonization Task Force (GHTF).

In conjunction with Singapore's Health Sciences Authority (HSA), the TGA co-hosted a highly successful 9th GHTF Conference in Singapore on 12-16 May 2002. The two agencies also co-hosted an equally successful GHTF training event: the 2nd APEC Seminar on the Harmonization of Medical Device Regulations, on 17-18 May 2002.

Both events were heavily attended and the Conference was the largest GHTF gathering to date, with 220 delegates representing 29 countries. 180 delegates (primarily regulators and industry representatives from countries with developing regulatory systems) attended the APEC Seminar. The dedicated efforts made by members of the GHTF Steering Committee and Study Groups, representing Australia, Japan, Europe, USA and Canada were a significant contributing factor to the success of the events.

All delegates at the Conference benefited from an exciting and interactive program that included meetings of the four GHTF Study Groups, the 4th Meeting of the GHTF Steering Committee, a Poster Presentation Session, Exhibition Booths set up by the local industry, and regional information sessions on new and emerging regulatory systems (which focused upon the Asian Economies, Latin and Central American Economies and China).

The Conference also featured three concurrent Workshop Sessions on the Global Medical Devices Nomenclature (GMDN), Evaluation of the draft World Health Organization (WHO) Guidelines for the Development of Medical Device Regulations and the Regulation and Supply of Refurbished Medical Devices.

The major highlight of the Conference was the one-and-a-half day GHTF Plenary which included the official Welcoming Address by Dr Balaji Sadasivan, Singapore's Minister of State (Health and Environment), the Keynote Address by Ms Catherine Livingstone, Chairman of the CSIRO Board, and individual Sessions on the Global Regulatory Model, New and Emerging Technologies, and The Total Product Life Cycle: A Focus on Postmarket Surveillance and Vigilance.

Ms Livingstone delivered a dynamic insight to the medical devices sector from her previous role as a Chief Executive of a medical device manufacturer and from her current role looking at the wider applications of research. She highlighted the impact that the genomic revolution, nanotechnology, miniaturisation and computing advances will have on the medical devices sector.

This theme was progressed by Plenary Session 2, New and Emerging Technologies, which was moderated by Dr David Jefferys, Chief Executive of the UK Medical Devices Agency. A number of government and industry speakers shared their views on the range of technologies they believe may emerge over the next five years. Delegates noted with significant interest, the high degree of commonality between the views.

In the subsequent panel discussion, the general conclusion emerged that it would be valuable for the GHTF to take this issue forward. The suggestion is that a timely guidance document be produced by the GHTF rather than requirements being generated independently by national authorities which would then have to be harmonised by the GHTF. This issue will now be taken forward into the 5th Steering Committee meeting (which will be the first under Japan's Chairmanship of the GHTF).

Dr Clarence Tan, Chief Executive Officer of the HSA, moderated the third Plenary Session, The Global Regulatory Model. The Session commenced with a highly informative overview of the global medical device regulatory model by a US industry member of the GHTF Steering Committee.

The highlight of the Session was "The Scorecard", where Steering Committee members, representing regulatory authorities from the five GHTF Founding Members, reported on progress with the implementation of harmonised GHTF Guidance Documents into their national regulatory systems.

The GHTF has had considerable success over the last decade and this was impressively highlighted by "The Scorecard". Some countries/regions have been able to move more rapidly than others since they have currently been implementing new legislation. Nonetheless, all Founding Members have made significant use of the GHTF documents.

Mr Terry Slater, the TGA National Manager, moderated the fourth Plenary Session, The Total Product Life Cycle: A Focus on Postmarket Surveillance and Vigilance. Dr Jefferys, Dr David Feigal Jr (Director, Centre for Devices and Radiological Health, US FDA) and Mr Roland Gerard (representing European industry) joined Mr Slater in highlighting that postmarketing surveillance covers a broad range of techniques.

These range from the simple recording of customer complaints through to the use of national registries, sophisticated longitudinal databases, the use of case control studies and, on occasions, using "a nested study" within a larger case control study.

The discussion period noted that postmarketing surveillance is not just about new or high risk products. The devices sector also has to be geared for addressing long-term safety issues or problems which may emerge from relatively minor changes in manufacturing. Equally, it was also recognised that low risk devices are not without hazards.

The 9th Conference provided an excellent opportunity to demonstrate the success the GHTF has achieved in the past. More importantly, it demonstrated there is a strong strategic direction for the future. The GHTF still has a major role to play and now has a clear direction for the future. It is an excellent demonstration of industry and regulators working together in partnership for the benefit of the public health. All Members now look forward to working very closely with our Japanese colleagues, who assume the GHTF Chair on 1 July 2002 for the following 18-month period.

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2nd APEC Seminar on the Harmonization of Medical Device Regulations

All delegates to the APEC Seminar benefited from a program which featured approximately 20 expert "trainers" from the GHTF Study Groups.

Topics included an overview of the GHTF, a presentation on the global medical device market and regulatory harmonisation, and presentations by members of the four Study Groups on Quality Systems and Auditing requirements, Postmarket Surveillance requirements and the harmonised approaches to medical device registration, classification and approval.

The Seminar also included sessions on the implementation of GHTF recommendations by the Founding Members and countries with developing regulatory systems.

The TGA extends its sincere thanks to all individuals and organisations who contributed towards the success of the 9th GHTF Conference and 2nd APEC Seminar held under Australia's Chairmanship of the GHTF.

Health Sciences Authority, Singapore, visit TGA

Between 29 April and 3 May 2002, the TGA Laboratories provided a training program on the control of biological and biotechnology products for eight officers from the Health Sciences Authority, Singapore.

The officers were from various professional disciplines including medical science, biochemistry, pharmacology, analytical science and pharmacy. They were also involved in administration and regulatory evaluation across several Centres such as Centre for Pharmaceutical Administration, Centre for Transfusion Medicine, Centre for Analytical Sciences and Centre for Drug Evaluation.

The training program provided the officers with an overview of the TGA and included sessions on biological and biotechnology products, viral safety, clinical evaluation of vaccines, regulation of vaccines, sterility testing, blood and blood products.

HSA - TGA Memorandum of Intention of Cooperation

While together in Singapore, Mr Slater and Dr Tan signed a Memorandum of Intention of Cooperation between the TGA and the HSA.

This occurred at a Signing Ceremony on Wednesday, 15 May 2002, which was attended by more than one hundred invited guests. Singapore's Minister of State (Health and Environment), Dr Balaji Sadasivan, was the Guest of Honour at the Ceremony.

Ms Trish Worth MP, Parliamentary Secretary to the Minister for Health and Ageing, was unable to attend this event due to parliamentary commitments. The Australian High Commissioner to Singapore, His Excellency Mr Gary Quinlan, represented Ms Worth at the Ceremony.

The MoI provides for exchanges of information, training and scientific collaborations between the TGA and the HSA. This will further consolidate the role and importance of Australia as a leading regulator in the Region. The agreement will also further strengthen the existing Mutual Recognition Agreement on pharmaceutical manufacturing practices between Australia and Singapore signed in February 2001.

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Other international visitors and training

As a generally accepted centre of excellence on medicines and medical device regulation, the TGA continuously collaborates with regulators and international organisations, particularly in the Asia/Pacific Region.

In mid-April 2002, the TGA and the Papua New Guinea National Department of Health signed a MOU in order to facilitate the cooperation in the regulation of medicines and medical devices.

Over the past few months, the TGA had visitors from the WHO Western Pacific Regional Office, the Japanese pharmaceutical industry and the Shanghai Municipal Drug Administration of China.

The TGA has provided several training programs to the Health Sciences Authority of Singapore, the National Agency of Drug and Food Control of Indonesia, the Bureau of Pharmaceutical Control of Malaysia, the Department of Drug Administration of Nepal and the Food and Drug Administration of Thailand. These training programs are sponsored by WHO, AusAID or various Australian and overseas governments.

A senior TGA officer was invited as an advisory committee member and key speaker at two international workshops on the regulation of traditional medicines in Hong Kong and Beijing respectively.

Dr Brian Priestly, Director of TGA Laboratories, attended the annual meeting of the Official Medicines Control Laboratories (OMCL) held in Bilthoven, the Netherlands, on 13-16 May 2002. He also attended the meeting of the International Laboratory Forum on Counterfeit Medicines held in Chester, England, on 20-23 May 2002.

TGA's recent international activities in blood regulation

Dr Albert Farrugia was invited by the New Zealand Blood Service to participate in a Workshop on Precautionary Measures to reduce the risk of TSE transmission by blood and blood products. The workshop was held on 30 April 2002 in Wellington.

Dr Farrugia gave a presentation on "Reducing TSE risks in plasma derivatives through fractionation-mediated clearance" and contributed to the formulation of recommendations to the New Zealand authorities on how to continue minimising TSE risks in the New Zealand blood supply.

Dr Farrugia also attended the International Congress of the World Federation of Haemophilia in Seville, Spain, on 19-24 May 2002. He delivered the keynote address on "Safety of therapeutic products for haemophilia-current and future perspectives" as well as talks on variant CJD issues, regulatory approaches and supply.