Department of health and ageing annual report 2002-03
OUTCOME 1 POPULATION HEALTH AND SAFETY
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- OUTCOME 1 THERAPEUTIC GOODS ADMINISTRATION
- Progress with Trans-Tasman Agency
- Performance Indicators (Effectiveness Indicators)
- OUTCOME SUMMARY—THE YEAR IN REVIEW
- Memorandum of Intent with Singapore
- Legislative Changes Following Pan Licence Suspension and Product Recall
- Progress with Trans-Tasman Regulatory Agency
- New Australian Medical Devices Regulatory System
- Strategic Information Management Environment
- Code of GMP for Medicinal Products
- Review of the TGA’s Auditing and Licensing of GMP
- Tamper Evident Packaging
- Development of a New Regulatory Framework for In-Vitro Diagnostic Devices
- National Regulatory Framework for Human Tissues and Emerging Biological Therapies
- Chair of the WHO Global Collaboration for Blood Safety Policy Group
- Participation in Council of Europe Committee of Experts in Quality Assurance in Blood Transfusion
- Australian Regulatory Guidelines for Medicines
- Gene Technology Regulation
- Cost Recovery System for OGTR
- Surveillance Success Stories
- International Anti-Counterfeiting Strategies
- FDA Award for Joint Investigation of Pharmaceutical Crime
- PART 2: PERFORMANCE INFORMATION
OUTCOME 1 POPULATION HEALTH AND SAFETY(Therapeutic Goods Administration)Did you know...?Nearly all medicines and medical devices have to be included on a register, called the Australian Register of Therapeutic Goods, before they can be marketed in Australia. You can access information on these products at OUTCOME 1 THERAPEUTIC GOODS ADMINISTRATIONPART 1: OUTCOME PERFORMANCE REPORTMajor AchievementsMemorandum of Intent with SingaporeThe Therapeutic Goods Administration (TGA) and the Health Sciences Authority (HSA) of Singapore have signed an agreement under which the HSA will recognise the TGA’s approvals for the marketing of medicines and medical devices. Progress with Trans-Tasman AgencyThe Australian and New Zealand Governments agreed to the establishment of a trans-Tasman agency to regulate therapeutic products. A treaty to give effect to the agreement is expected to be signed later in 2003. New Australian Medical Devices Regulatory SystemA new regulatory system for medical devices in Australia came into effect on 4 October 2002. Performance Indicators (Effectiveness Indicators)
The Department’s performance against these indicators is discussed in the following outcome summary. Specific references to these indicators are marked by footnotes. OUTCOME SUMMARY—THE YEAR IN REVIEWA key objective of the TGA is the regulation of therapeutic products in Australia to ensure they meet high standards of safety, quality and efficacy and are made available to the community in a timely manner. During 2002-03, the TGA has again achieved this objective while working successfully with stakeholders and other regulatory agencies internationally to address the increasing demands of rapidly developing technology and consumer expectations of faster availability of a wider range of therapeutic goods. There were approximately 59,400 products on the Australian Register of Therapeutic Goods as at 30 June 2003, compared with 59,800 a year earlier. The drop in the number of products is attributable to the regulatory action taken in respect of Pan Pharmaceuticals Limited, which resulted in over 1,800 products manufactured by Pan, or containing ingredients manufactured by Pan, being cancelled from the Register. From 1 July 1998, the TGA has been required by the Australian Government to fully recover its operating costs for all activities that fall within the scope of the Therapeutic Goods Act 1989, including regulation of industry and the TGA’s public health responsibilities. The TGA achieves cost recovery in several ways: by charging fees for the evaluation of applications to include products in the Australian Register of Therapeutic Goods, or to amend details of products currently in the Register; by charging fees for issuing manufacturing licences and for undertaking inspections and audits of manufacturing premises; and by levying annual charges for products which are included in the Register. The TGA has one main effectiveness measure relating to therapeutic goods, which is the number of products on the Australian Register of Therapeutic Goods requiring recall or cancellation for safety-related reasons as a result of post market surveillance.44 During 2002-03 there was a significant increase in the number of products recalled or cancelled, due largely to the regulatory action taken by the TGA in April 2003 to suspend the licence to manufacture therapeutic goods which was held by Pan Pharmaceuticals Limited and to cancel and/or recall products manufactured by Pan. The TGA cancelled a total of 232 products in the domestic market from the Register for safety-related reasons, of which 219 were products sponsored by Pan. The TGA also recalled 1,834 products for safety-related reasons, including 1,618 products containing ingredients manufactured by Pan. In addition, 1,659 export-only products containing ingredients manufactured by Pan were cancelled from the register. This means about 6.25 per cent of the total number of products on the Register were affected by cancellation or recall. It compares with 212 recalls and cancellations for safety-related reasons in the previous year, representing about 0.35 per cent of the total number of products on the Register at that time.
These amendments tightened the existing requirements placed on manufacturers and sponsors of therapeutic goods to further ensure the quality, safety and efficacy of therapeutic goods that are supplied in Australia or exported from Australia. The amendments increase maximum penalties for a range of existing offences; create a range of new offences such as falsifying documents relating to therapeutic goods regulation; expand compulsory public notification and recall provisions; insert a ‘fit and proper person’ test in relation to manufacturing licences and conformity assessment certificates; require better identification of therapeutic goods in the event of a recall; and require inclusion of manufacturer details on the labels of medicines. Progress with Trans-Tasman Regulatory AgencyThe Australian and New Zealand Governments agreed to establish a trans-Tasman agency to regulate therapeutic products, following consultations in the second half of 2002 with a wide range of interest groups as well as with the States and Territories. This initiative is intended to harmonise therapeutic goods regulation between both countries and responds to the Australian Government’s obligations under the Trans-Tasman Mutual Recognition Arrangement (which seeks to lessen regulatory and trade barriers between Australia and New Zealand). As a result of this decision, work was undertaken on the development of the treaty text and draft legislation to create the institutional and regulatory framework for the agency. The agency is expected to become operational on 1 July 2005. New Australian Medical Devices Regulatory SystemA new regulatory system for medical devices in Australia came into effect in October 2002. The new internationally harmonised regulatory system places Australia at the forefront of world’s best practice for the regulation of medical devices. The new legislation is based on the principles of the Global Harmonisation Task Force, which comprises the world’s key regulators from the USA, Canada, Europe, Australia and Japan. This new system is supported by the introduction of the world’s first web-based electronic application lodgement system for medical devices. Along with the web-based application lodgement system companies can now access information electronically on their medical device and medicinal products by viewing their own records included in the Australian Register of Therapeutic Goods. Strategic Information Management EnvironmentAs part of the ongoing development of the TGA’s Strategic Information Management Environment (SIME), the Australian Register of Therapeutic Goods was moved from a mainframe-based system onto a new Oracle- based relational database. This new database allows more comprehensive searching of information held in the Register, and was instrumental in allowing the TGA to identify more quickly and with greater certainty than would otherwise have been possible the suppliers and products affected by the suspension of Pan Pharmaceuticals’ licence to manufacture therapeutic goods. The Register holds detailed information on almost 60,000 therapeutic goods. Other major outcomes achieved under SIME were: implementation of a computerised workflow system (Premier) for tracking the evaluation and registration of prescription medicines. This system allows sponsors of prescription medicines to monitor, via a secure internet- based system, the progress of their applications being evaluated by the TGA; implementation of a computerised system to record the details of adverse drug reaction reports received by the TGA; implementation of a computerised system which allows sponsors to lodge applications for approval of medical devices electronically. This system meets the obligations placed on the TGA by the Therapeutic Goods Amendment (Medical Devices) Act 2002; providing sponsors of therapeutic goods with direct access via the internet to detailed records relating to their own products on the Register; and providing consumers with access via the internet to a limited set of data about all products on the Register.
The TGA proposes that compliance with the Code of Practice will become mandatory under therapeutic goods legislation as a Therapeutic Goods Order with effect in early 2004, with a one-year transition period during which sponsors will need to ensure compliance. The Industry Government Crisis Management Committee in June 2003 finalised a consumer awareness brochure on the safe use of medicines including the importance of tamper evident packaging. The brochures will be released through pharmacies and other retail outlets in the next few months. The development of the brochure followed the paracetamol tampering and extortion threats in 2000-01 and recognition of the need for medicines to have appropriate tamper evident seals/packaging to minimise the risks to consumers.
In April 2003 the Working Group released for public consultation a detailed discussion paper describing a proposal for a new regulatory framework for IVDs. The release of the discussion paper was followed by consultation sessions in most capital cities. The proposed regulatory model was considered by the Australian Health Ministers’ Conference in July 2003. National Regulatory Framework for Human Tissues and Emerging Biological TherapiesIn late 2002, the TGA commenced consultation with key stakeholders on the development of a national regulatory framework for the rapidly developing area of human tissues and biological therapies. The outcomes of this consultation formed the basis for a discussion paper, which was released for public consultation in April 2003. Consultation sessions on the discussion paper were held in each Australian capital city (except Hobart and Darwin) in April and May 2003. A detailed report is in the process of being prepared outlining the preferred regulatory approach to the regulation of human tissues and biological therapies. Once finalised the report will be provided to the Australian Health Ministers’ Advisory Council and the Australian Health Ministers’ Conference for consideration. Chair of the WHO Global Collaboration for Blood Safety Policy GroupIn November 2002, Dr Albert Farrugia of the TGA assumed the Chair of the Policy Group of the Global Collaboration for Blood Safety (GCBS). The Policy Group’s role includes the development of optimal policy making guidelines for public health officials engaged in blood safety decision making. The WHO is a member of the GCBS and also provides its secretariat. During 2002-03, the Policy Group prepared an aide memoire on blood safety which will assist policy makers in health agencies around the world to make decisions relating to the safety of blood. Participation in Council of Europe Committee of Experts in Quality Assurance in Blood TransfusionIn February 2003 the TGA was charged with the development of new chapters relating to malarial testing and leucocyte depletion in the Council of Europe’s Guide to the Quality Assurance and use of Blood Components. This guide is an internationally recognised standard in the field and was adopted by the TGA as Australia’s national standard for fresh blood in 2000. As a result of the work carried out by the TGA, the Australian Red Cross Blood Service has now implemented new haemoglobin level requirements that will assist in protecting the health of Australian blood donors. Australian Regulatory Guidelines for MedicinesThe TGA has released the new Australian Regulatory Guidelines for OTC Medicines, which come into effect on 1 July 2003. These guidelines are intended to assist those wishing to apply for approval of over-the-counter medicines to meet the regulatory requirements for evaluation and registration of these products. The TGA is also undertaking the development of the Australian Regulatory Guidelines for Complementary Medicines, and a draft of Part III: Evaluation of Complementary Medicine Substances of the guidelines has been released for stakeholder comment. These documents can be found on the TGA website at Gene Technology RegulationThe TGA has administrative responsibility for the Office of the Gene Technology Regulator (OGTR), which was established in June 2001 to provide administrative support to the Gene Technology Regulator in the performance of her functions under the Gene Technology Act 2000. The Act introduces a national scheme for the regulation of genetically modified organisms in Australia, in order to protect the health and safety of Australians and the Australian environment by identifying risks posed by or as a result of gene technology, and to manage those risks by regulating certain dealings with Genetically Modified Organisms (GMOs). The OGTR has one main effectiveness measure, which is 100 per cent compliance for all licensed dealings, certifications and accreditations in relation to genetically modified organisms.45 In 2002-03 the OGTR discovered one instance of non-compliance amongst the 192 licences not involving release of GMOs into the environment, and seven instances of non- compliance amongst the 77 licences involving release of GMOs. Remedial action was taken in each of the eight instances of non-compliance so that the risk to human health and the environment was negligible. Further information is available in the OGTR Quarterly Reports. Cost Recovery System for OGTRA review was commissioned in July 2002 by the Office of the Gene Technology Regulator (OGTR) to seek feedback from the OGTR’s stakeholders on the implications of cost recovery, if implemented from 1 July 2003. After consultation with organisations undertaking gene technology research, the report concluded that the Australian market will be unable to support cost recovery for at least another two years. The Australian Government has agreed to provide funding to the OGTR until 30 June 2005. Chemicals RegulationThe Office of Chemical Safety (OCS), which includes the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) provides advice on potential public health risks posed by chemicals used in the community. This is achieved by conducting risk assessments and providing toxicological advice to other regulatory authorities on public health issues relating to agricultural, veterinary and industrial chemicals. It also provides technical policy advice on national and international chemicals negotiations and treaty matters. The OCS compliance program contributed towards the National Drug Strategy by implementing controls to deliver the licit end use of scheduled and other controlled substances such as narcotics. Major activities during 2002-03 include the: contribution to community protection from drug diversion and hence illicit use of controlled substances by monitoring some 1.5 million domestic movements of such substances; final report of NICNAS’s Low Regulatory Concern Chemicals Taskforce. Implementation will introduce flexibility and optimise risk-resource allocation in the industrial chemicals assessment process to allow fast tracking of the introduction of chemicals of low risk (including chemicals of low hazard or low risk or controlled exposure) or previously assessed chemicals without compromising public health, worker safety or the environment; and progress report on regulatory initiatives in the Chemicals and Plastics Action Agenda indicated that the chemical regulation system fully complied with best practice regulation and continued to deliver high quality health and safety protection to the community from risks posed by industrial chemicals, pesticides and cosmetics.
Surveillance ActivitiesThe TGA’s Surveillance Unit has continued throughout the year to actively monitor compliance with the provisions of the Therapeutic Goods Act 1989 and other relevant legislation. The TGA collects intelligence in relation to manufacture of and trade in therapeutic goods, undertakes investigations and instigates prosecutions. The legislation is enforced to ensure the quality and safety of therapeutic goods and to protect the integrity of Australia’s therapeutic goods industry. The Unit actively liaises with other Australian and overseas government departments and with industry, in achieving this role. During the period 1 July 2002 to 30 June 2003, 460 new referrals were received. In addition to those referrals being actioned, an additional 89 outstanding matters were attended to. Outcomes of those investigations can range from, but are not limited to, advice and counselling, formal warnings and regulatory visits for minor breaches of the Act up to and including criminal prosecutions for more serious offences.
A Brisbane businessman was fined $21,000 for illegally exporting blood glucose test strips to a number of overseas countries. The diversion of these products, which were legitimately supplied in Australia, posed a significant public health risk in overseas markets because they were not correctly calibrated for use overseas and would have produced false blood glucose readings and led to incorrect insulin dosages. Curacel International Pty Ltd was fined $84,000 for the manufacture and supply of counterfeit medicines, and a director of the company was fined $12,000 for his involvement in a label-swapping scam. The products contained substances not permitted in over-the-counter medicines, and one product had been re-bottled and re-labelled with false expiry dates. This was the first conviction under the anti- counterfeiting provisions which were inserted into the Therapeutic Goods Act 1989 in 2000 following WHO recommendations on measures to combat the international trade in counterfeit medicines. From May 2003, the maximum penalty for a company convicted of any therapeutic good counterfeiting offence now exceeds one million dollars. A debarred Melbourne lawyer and his partner were sentenced in the USA to lengthy prison terms on charges related to illegally offering prescription drugs over a US-based internet site. This trial resulted from lengthy investigations by the US Food and Drug Administration (FDA), assisted by the TGA’s Surveillance Unit, into the activities of the Norfolk Men’s Clinic. The offences included conspiracy to commit money laundering, mail fraud, dispensing misbranded drugs and operating a drug repackaging facility that was not registered with the FDA. Health Promotions International Pty Ltd was fined $60,000 for supplying medicines not included in the Australian Register of Therapeutic Goods. The company supplied bovine tracheal cartilage in oral liquid and capsule form as a treatment for cancer, and operated through an Australian web site. The company made unsubstantiated claims about the value of its products as cancer remedies.
Performance Information for Departmental Outputs
appropriate national policies and controls for medicines, medical devices, chemicals, gene technology and blood and blood products; and collaboration with international stakeholders.
Agency specific service delivery Information, including: publication of bulletins, reports and newsletters; the internet information site; operation of TGA customer service feedback processes; and operation of a TGA information telephone service.
Regulatory activity, through: pre-market assessment of therapeutic goods at a level appropriate to assessed risk; licensing of manufacturers of therapeutic goods including their compliance with the principles of Good Manufacturing Practice; post-market surveillance and other activities based on risk management and targeted testing of therapeutic goods; provision of advice on the public health impact of agricultural and veterinary chemicals which takes into account national and internationally recognised standards; pre-introduction assessment of new industrial chemicals and review of priority existing industrial chemicals (including environmental risk); and licensing of dealings with GMOs.
Figure 1.2: Prescription Medicines 2002-03 Figure 1.3: Other therapeutic goods 2002-03 Figure 1.4: Applications and notifications 2002-03 Directory: sites -> default -> files files -> Answer True False 2 points Question 2 files -> Northern England’s set-jetting locations files -> Nstructions for Acquiring Excess Equipment online, through the 1033 Program files -> Occupational health and safety files -> The Black Panther Party’s Ten Point Program files -> International programs roel profile files -> Fermi Questions a guide for Teachers, Students, and Event Supervisors Lloyd Abrams, Ph. D. DuPont Company, cr&D/ccas experimental Station Wilmington, de 19880 files -> Personal Information Name: Maha Al-Ammari Nationality: Saudi Relationship Status Download 1.71 Mb. Share with your friends:
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