National Industrial Chemicals Notification and Assessment Scheme

As a result of the administrative order changes following the last Federal election the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is now part of the TGA.

NICNAS assesses industrial chemicals for their health and environmental effects and makes recommendations for safe use.

Further information about NICNAS is available on its website at: http://www.nicnas.gov.au, including the Chemical Gazette which is published on the web site on the first Tuesday of each month.

Their freecall number is 1800 638 528 and further contact details are available at: http://www.nicnas.gov.au/contact.asp

Trans-Tasman Harmonisation

Australia's TGA and New Zealand's Medsafe are progressing regulatory harmonisation proposals. Both countries agree in principle that a joint trans-Tasman therapeutic goods agency is the appropriate way to address therapeutic goods' temporary exemption from the Trans-Tasman Mutual Recognition Arrangement, a preferential trade agreement between the two countries. But a cost benefit analysis and other issues are being addressed before final approval is given. The cost benefit analysis was presented recently to the Australian government. For the outcome, see the joint agency project web site <http://www.anztpa.org>.

Informal consultation with key industry, consumer and government stakeholders has been underway for some time. A more formal discussion paper will be released in early May. In August both Governments will consider the best way to establish the agency and the regulatory regime that it will administer.

Present thinking would see a treaty in which Australia and New Zealand agree on the broad objectives so the agency could set standards; give market approval; license and monitor manufacturing; and undertake in both countries TGA's and Medsafe's current pre and post market activities. The agency would cover the same range of therapeutic goods that TGA regulates. The new regulatory regime would apply to New Zealand's complementary medicines/dietary supplements and medical devices.

The precise regulatory controls will be settled after considering submissions made on the May discussion paper. In essence controls will be commensurate with risk. The agency's managing director would be responsible for regulatory decisions that deliver common regulatory outcomes from a single application. That power could be delegated, just as the Secretary of the Department now delegates decision making power. Expert committees would advise the decision maker. Either country could 'opt out' in certain circumstances.

The agency will be shaped in the treaty and by Australian legislation. Both Governments will consider that shape in July. The agency would be responsible to a Ministerial Council of two, the Australian and New Zealand Ministers of Health. It will be directly accountable to both Ministers and both Parliaments. Australian officials favour a model under which the treaty sets up the agency's board and an Australian Act gives the agency corporate status.

To give both countries appropriate 'voice' the framework envisages the bulk of the regulatory requirements being made in mandatory, enforceable rules made by the Ministerial Council and orders like current TGOs, both subject to disallowance by either Parliament.

More information:

Changes to Structure of TGA Laboratories Branch

TGA Laboratories' Director, Dr Joe Smith has left to take up an appointment with the National Registration Authority. Dr Brian Priestly has taken over the role of Director. Brian has been with the TGA since 1996 as Scientific Director in the Chemicals and Nonprescription Medicines Branch with responsibility for toxicological assessments and public health advice of agricultural, veterinary, industrial and other hazardous chemicals. He has been the TGA member of the National Drug & Poison Schedule Committee (NDPSC) since it was reformed in 1999 and represented the Commonwealth on the Steering Committee for the Galbally Review of poison scheduling. Prior to joining the Department in 1992, he had an academic appointment at the University of Adelaide with interests in pharmacology and toxicology.

Dr Garry Hopkins has been appointed Manager of Prescription Medicines Services for the laboratories and takes on the role of Scientific Leader of the Biochemistry Group within TGAL. Prior to joining the TGA he held senior management positions in the pharmaceutical industry with overall responsibilities for clinical research and regulatory affairs. In his new position Garry will be responsible for ensuring the delivery of evaluation and testing services to support the TGA's prescription medicine regulatory program.

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19th NRL Workshop on Serology

The 19th NRL Workshop on Serology will be held from 20-22 August 2002 at the Hilton on the Park in Melbourne.

Adoption of British Pharmacopoeia 2001

With effect 1 December 2001, the British Pharmacopoeia 2001 (BP 2001) became the edition of the British Pharmacopoeia defined under subsection 3(1) of the Therapeutic Goods Act 1989 as the principal standard applying to therapeutic goods in Australia. An order to this effect was published in the Commonwealth of Australia Gazette on 28 November 2001 (GN 47).

Adoption of BP 2001 was recommended by the Therapeutic Goods Committee at its November 2001 meeting followed by consultation with the peak medicine and medical device industry associations. Adoption of new editions of the British Pharmacopoeia is an annual process that maintains parity with comparable countries in standards for therapeutic goods.

WHO Assessment of Australia's Vaccine Regulatory System

The ATT (Access To Technologies) team, of Vaccines and Biologicals, Health Technology & Pharmaceuticals cluster, World Health Organisation, have an ongoing programme to improve the quality of vaccines used around the world which includes strengthening the capacity of National Regulatory Authorities to assure vaccine quality. WHO rely on the National Regulatory Authority of the country of origin for ongoing assurance of the quality of vaccines supplied through UN agencies, and also assess vaccine regulation in member states, with priority for vaccine producing countries. An outcome of the assessment process is strengthening of vaccine regulation through the formulation of an Institutional Development Plan. This Plan can include appropriate training for staff of the NRA, coordinated through the WHO Global Training Network (GTN). TGA is one of the training institutions in the GTN.

TGA has a long-term involvement in assisting WHO in this regulatory strengthening, with officers involved in the first Regional Workshop in Manila in 1997, which commenced the development of a set of indicators for assessing the vaccine regulatory system. TGA granted Chris Rolls two periods of Leave Without Pay in 2000 and 2001 to work for WHO in ATT (Regulatory Strengthening) utilising these indicators for 15 in-depth assessments of the performance of vaccine regulatory systems in vaccine producing and procuring countries. Furthermore, the International Vaccine Institute (IVI) contracted TGA (Dr Peter Bird and Dr Drew Meek) to participate in two of these assessments during 2001.

In November 2001, the tables were turned, when a WHO team comprising Lahouari Belgharbi (ATT Regulatory Strengthening), Dr Nora Dellepiane (ATT Vaccine Supply) and Dr Jurgen Scherer (Paul Ehrlich Institute, Germany) did a three day assessment of the Australian vaccine regulatory system. The standard set of indicators, which measure the performance of the overall system and the critical regulatory functions of Licensing, Surveillance of Vaccine Performance and Adverse Events, Laboratory Testing, Lot Release, GMP Inspection, and Clinical Evaluation, were applied rigorously to the TGA. This independent review provided valuable feedback on this aspect of TGA's role.

This WHO assessment confirmed, as expected, that TGA fulfils all the critical vaccine regulatory functions, reassuring the world of the high standard of vaccine regulation in Australia.

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TGA's involvement in blood safety issues internationally

TGA is a member of WHO's Global Collaboration for Blood Safety (GCBS), a forum of international experts in blood safety brought together by WHO to develop policy recommendations and strategies for governments and blood agencies. The forum is drawn from government regulatory and policy agencies, blood system experts from the collection and fractionation sectors and members of professional organisations. The GCBS is structured into three Working Groups: Plasma issues, Policy Development and Quality Assurance, and is overseen by a steering committee that develops the agenda for the annual meetings and monitors the outcomes of the Working Groups. The TGA is represented by Dr Albert Farrugia who is the official rapporteur for the Collaboration as well as serving on the steering committee through his chairmanship of the plasma issues group. A web page for the GCBS is under construction at WHO, who also provides the secretariat and other assistance to the collaboration.

At the GCBS' last meeting in November 2001 issues discussed and policy developments included:

Development of a global standard for quality management and accreditation in blood systems Production of an Aide-Memoir and Fact Sheets on Plasma Quality and Safety Issues by the Plasma Group Consideration of Pathogen Inactivation Technologies and their place in assuring blood safety Assessment of differential pricing mechanisms in assisting access to blood safety technologies Initiation of a Guideline on good policy practices in blood safety.

In addition Dr Farrugia has provided the principal input into the WHO's Weekly Epidemiological Record in its most recent assessment of the risk of variant CJD through blood (http://www.who.int/docstore/wer/pdf/2001/wer7650.pdf (pdf,274kb)).

Although the GCBS' recommendations are not binding on the member organisations, the members are charged with using GCBS principles and outcomes in influencing blood policy worldwide. The diverse geographical and professional composition of the GCBS ensures that these principles are given a wide exposure in the environments that require them,

The TGA is now an observer member in the two principal agencies that influence blood products in Europe, the Council of Europe Committee of Experts in Blood Transfusion and the European Pharmacopoeia Expert Group on Plasma Products. Through its membership of these bodies TGA is able to access developments in blood products in a very rapid fashion and is also able to comment and influence policy and guidance development in ways that favour blood safety in Australia.

Dr Albert Farrugia's appointment as the offical adviser on blood safety to the World Federation of Haemophilia (WFH) has resulted in the production of an assessment of variant CJD risks from certain coagulation factors which has been widely distributed and placed on the WFH's web site. Further work is ongoing including the development of a regulatory handbook for governments wishing to access haemophilia products and a handbook on basic safety and manufacturing issues.

Therapeutic Goods Committee 19th meeting report

The 19th meeting of the Therapeutic Goods Committee (TGC) was held on 8 November 2001. The main outcomes of the meeting were:

• Adoption of new Committee processes for ratification of resolutions and minutes and the introduction of public release of key meeting outcomes on the TGA website;
• Establishment of a Subcommittee on Manufacturing Principles to advise on principles to be observed in the manufacture of therapeutic goods for human use, with the Subcommittee's initial task being consideration of a replacement for the current Australian Code of Good Manufacturing Practice for Therapeutic Goods (Medicinal Products);
• Reconvening of the Subcommittee on Child Resistant Packaging to undertake further development of the proposed new Therapeutic Goods Order (TGO) for child-resistant packaging;
• Recommendations for:
  • Adoption of British Pharmacopoeia 2001 (BP 2001) with effect 1 December 2001 as the principle standard referenced under the Therapeutic Goods Act 1989;
  • Consultation by the TGA with stakeholders on revocation of TGO 29 'Standards for Ethanol', based on advice that major Australian distilleries are now able to comply fully with the requirements of the BP monograph for ethanol;
  • Adoption of a new TGO to specify standards to which medicines for export only may comply, introducing the United States Pharmacopoeia, the Japanese Pharmacopoeia and the European Pharmacopoeia as alternative standards to the current edition of the BP for these medicines; and
  • Progression by the TGA of the harmonisation of Australian Approved Names with recommended International Non-proprietary Names as a matter of priority.