Significant changes for the NDPSC

November saw the passing of a significant milestone in the history of the National Drugs and Poisons Schedule Committee (NDPSC) when the Committee established under the Therapeutic Goods Act 1989 met for the first time.

At their first meeting, which immediately followed the final meeting of the Australian Health Ministers' Advisory Council (AHMAC) NDPSC, the statutory NDPSC dealt with transitional matters to allow the transfer of authority from AHMAC to the Commonwealth. Having completed that task, the NDPSC then moved to its second meeting, which was conducted in line with normal procedures. The Secretariat is to be congratulated on facilitating the smooth conduct of this complex series of meetings.

Another significant milestone for the NDPSC is the invitation from the New Zealand Associate Minister of Health to Senator Tambling, Parliamentary Secretary to the Minister for Health and Aged Care, for NDPSC to participate in meetings of the New Zealand Medicines Classification Committee (MCC).

The composition of the new NDPSC remains the same as that of the AHMAC Committee. The legislation provides for representatives of all jurisdictions, the New Zealand and Australian agencies responsible for drugs and poisons, representatives of various sectors of the community including consumers, industry and practising pharmacists and relevant experts.

Dr Susan Alder, the Principal Medical Adviser to the TGA has been appointed as the new Chair of the NDPSC. She will take up her appointment on 1 January 2000. In the meantime Dr Alex Proudfoot, the Chair of the AHMAC NDPSC has been appointed to take the Committee through this transitional period.

While the move to a statutory committee has not led to any significant changes in the NDPSC decision making processes, its has enhanced the transparency of the process and will facilitate States and Territories adopting scheduling decisions by reference. Any further changes in the operation of the NDPSC will need to await the outcome of the Council of Australian Governments Review of Drugs Poisons and Controlled Substances Legislation, which is currently under way. That Review is due to report in July 2000.

Until the New Zealand legislation is changed there is no provision to enable an Australian member to be appointed to the MCC. However the invitation from the New Zealand Associate Minister for Health made it clear that the NDPSC member should participate to the maximum extent possible. In recognition of the importance of this invitation, Senator Tambling has asked that the Chair of the NDPSC represent the NDPSC on the MCC.

NDPSC has a long history dating back to 1954, when it was established by the National Health and Medical Research Council to facilitate greater uniformity in the regulation of drugs and poisons across Australia. In 1993 auspices for the Committee were transferred to the Australian Health Ministers' Advisory Council (AHMAC). With the agreement of all Health Ministers, the Therapeutic Goods Act 1989 was amended earlier this year to transfer responsibility for the Committee from AHMAC to the Commonwealth. Regulations to give effect to that amendment commenced on 16 September 1999.

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Key stakeholder briefing on medical device regulation

17 September 1999

Another important step has been taken towards the international harmonisation of Australia's system for regulating medical devices.

The Parliamentary Secretary to the Minister for Health and Aged Care, Senator Tambling unveiled a new, internationally harmonised, regulatory framework for medical devices to key Australian medical devices industry stakeholders at Parliament House in Canberra on 17 September 1999.

The event was attended by representatives of industry, consumers, professional associations, foreign delegations and the Federal/State Governments. It followed the Federal Government's decision on 14 September 1999 to:

• adopt the internationally accepted classification of the European Union;
• adopt the essential principles for safety and performance and vigilance requirements from the Global Harmonisation Task Force (GHTF);
• continue to play a leading role as one of the founding members of the GHTF to pursue the internationally harmonised model;
• maintain the TGA's role to:
  • approve products for supply in Australia; and
  • assess medical devices to European Standards under the Mutual Recognition Agreement with the European Community; and
• introduce legislation to enable this framework to be put into place as soon as possible.

The reforms include a risk-based device classification system, minimum safety and performance requirements, harmonised quality assurance systems for manufacturing, the use of international harmonised standards and a more comprehensive postmarket vigilance system.

Senator Tambling spoke of the importance of Australia's medical devices market, noting it is worth approximately $A1.5 billion which represents about one per cent of the global market.

Most of Australia's imports are from the United States and Europe. Over 60 per cent of our exports are to Asia.

Senator Tambling said the reforms would reduce red tape and "the nightmare of different regulations" for industry engaged in global trade, enable consumers to enjoy more timely access to new technology and apply the best international standards to ensure confidence in the safety and quality of the medical devices used.

He said since coming to office that the Government had supported Australia developing a high standard and competitive regulatory system for medical devices and had actively pursued international harmonisation as a principal member of the Australia/EC/USA/Canada/Japan medical device Global Harmonisation Task Force.

"The regulatory reforms will ensure Australia's medical device industry gains maximum benefits from existing and future international trade agreements," Senator Tambling said.

"For example, the reforms will assist the Mutual Recognition Agreement with the European Community signed in June 1998 and Australian traders will be able to access the European market in a timely manner."

"These new arrangements offer a more confident and comprehensive performance-based system which will improve the effectiveness of medical device regulation in Australia," Senator Tambling said.

Members of the Therapeutic Devices Evaluation Committee (TDEC), the Therapeutic Goods Committee and the Medical Device Harmonisation Working Party also attended the stakeholder briefing.

Afterwards, TDEC held its regular meeting and the Harmonisation Working Party met to explore issues concerned with regulatory reform implementation in more detail.

From left: Terry Slater, TGA National Manager, and Senator Tambling

Senator Tambling visits Vietnam, Thailand and China

On 6 November 1999, Senator the Hon Grant Tambling, Parliamentary Secretary for Health and Aged Care, led an official delegation to Vietnam, Thailand and China to advance cooperation in the area of medicines, medical devices and food, including discussions on the development of Memoranda of Mutual Cooperation with the relevant agencies. The delegation comprised representatives from the Department of Health and Aged Care, the Pharmacy Guild of Australia, the Pharmaceutical Society of Australia, the Australian Pharmaceutical Manufacturers Association, and the School of Pharmacy at the University of Sydney. The Department's representatives were Dr Susan Alder, Principal Medical Adviser, TGA, and Mr Graham Peachey, Director, Chemicals and Non-Prescription Medicines Branch, TGA.

Senator Tambling started his official visit in Vietnam where he visited the cities of Hanoi and Ho Chi Minh City and met with the Director General of the Drug Administration of Vietnam and the Vice Minister of Health. A visit was also made to the College of Pharmacy and University of Medical Sciences and Pharmacy in Hanoi. This was Senator Tambling's first official visit to Vietnam and discussion focussed on regulation of food and regulation of complementary medicines, including traditional medicines. He discussed the mutual benefits arising from the existing memorandum of understanding between Australia and Vietnam. The visit provided a useful opportunity to learn about the way Traditional Medicines are regulated in a country where they have played an important role for many centuries.

After Vietnam Senator Tambling and the delegation spent two days in Thailand. This visit also represented an opportunity to brief Thai officials on recent developments in food and medicines regulation in Australia, including Australia's health-based approach to Genetically Modified Organisms (GMOs) and changes to the regulation of Complementary Medicines. These developments have opened the way for further cooperation on these issues.

The Senator presented DIA/TGA fellowships to senior Thai Food Drug Administration officials, and secured the Minister for Public Health's agreement to exchange letters between Australia and Thailand to identify specific areas of bilateral cooperation on food and drug issues. Thai Health Authorities reiterated their commitment to regional harmonisation of regulatory standards ahead of the Asia Pacific Economic Cooperation (APEC) Workshop on the food/drug interface in Bangkok.

Senator Tambling's official visit was completed by a visit to China where he met with officials at the State Administration of Traditional Chinese Medicine (SATCM) in Beijing. Discussions were held with the Executive Vice Minister of Health, the Director of the State Drug Administration, Director-General of the Pharmaceuticals Division of the State Economic and Trade Commission, and the Director General of International Cooperation.

Senator Tambling secured agreement to develop a comprehensive bilateral arrangement between the TGA and China's State Drug Administration. It was also agreed that the existing agreement with the SATCM should continue, but be modified to reflect recent government restructuring. The Australian Ambassador to China hosted a welcome dinner for the delegation.

On his visit to Shanghai, Senator Tambling met with government, industry and researchers and cemented the commitments to bilateral cooperation made in Beijing. Austrade organised highly successful Industry roundtables in Beijing and Shanghai in which there was genuine commitment to further cooperation in trade, development and training opportunities in the area of Traditional Chinese Medicine.

Overall, the visit produced very successful results, particularly in the areas related to complementary medicines (Traditional Chinese Medicines) and the food/drug interface - including genetically modified food.

The delegation on a visit to Tongrentang corporation, Beijing
L to R: Julianne Quinn (Senator's Office), Senator Tambling, Tony Nunan (National President, Pharmaceutical Society of Australia) Sandy Tambling, Graham Peachey (Director, C&NPMB, TGA), Susan Alder (Principal Medical Adviser, TGA), John Bronger (National President, Pharmacy Guild of Australia), Rachel David (representing Australian Pharmaceutical Manufacturers Association), Basil Roufogalis, (Professor of Pharmaceutical Chemistry, Sydney University)