TGA Major Achievements || TGA Outcome Summary || TGA Performance Indicators
KEY STRATEGIC DIRECTIONS FOR 2004-05
The Therapeutic Goods Administration (TGA) group of regulators, which includes the TGA, the Office of the Gene Technology Regulator (OGTR) and the Office of Chemical Safety (OCS) - incorporating the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), is responsible for the regulation of therapeutic products, chemicals and gene technology in Australia.
Therapeutic Goods Act Legislative Amendments for the Australia-United States Free Trade Agreement (AUSFTA)
The TGA oversaw the implementation of the terms of the AUSFTA by amending the Therapeutic Goods Act 1989
. These amendments require that the applicant who is seeking marketing approval of medicines in Australia provide certifications that state that the applicant either does not believe it is infringing the Patents Act 1900,
or alternatively that the applicant is proposing to market the goods before the expiry of the term of a patent.
Implementation of the ANAO recommendations
In December 2004, the Australian National Audit Office (ANAO) tabled its report on the performance audit of the TGA’s regulation of non-prescription medicinal products. The report included 26 recommendations which addressed a range of issues within the broad categories of risk management, documentation and record keeping, and improvements in procedures for various administrative actions. The Department of Health and Ageing agreed with the recommendations and subsequently engaged Deloitte to review implementation progress, as well as develop broader recommendations on issues such as governance, procedural improvement, risk management and performance management.
As part of the TGA’s commitment to continuous improvement, the TGA has already either completed or made substantial progress in implementing the recommendations. The TGA is taking the opportunity to look more broadly across the full range of its activities and not confine the lessons learned to the non-prescription medicines sector.
Establishment of the Trans-Tasman Therapeutic Products Regulatory Scheme
In February 2005, the Australian and New Zealand Governments agreed to defer the start-up of the new Trans-Tasman Therapeutic Products Regulatory Scheme to facilitate further consultation with industry, consumers and other interested parties. A new joint regulatory agency will be created to replace Australia’s TGA and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).
Australia-Canada Mutual Recognition Agreement on Medicines Good Manufacturing Practice Inspection and Batch Certification
In March 2005, the governments of Australia and Canada signed a bilateral treaty called the Australia-Canada Mutual Recognition Agreement (MRA) on Medicines Good Manufacturing Practice (GMP). The MRA allows for recognition of the other’s GMP assessments about the safety and quality of new pharmaceuticals seeking to enter their respective markets.
The MRA was the result of three years of productive interchange and collaboration between the TGA and the Health Products and Food Branch, Health Canada. This MRA allows manufacturer’s batch certifications to be recognised by the other party without re-analysis at the point of import. The treaty enhances bilateral regulatory cooperation, while allowing each country to maintain its own standards to preserve public health and safety. By reducing regulatory costs and duplication, the MRA will enhance the competitiveness of both Australian and Canadian exports by significantly speeding up the process of getting life saving medicines onto the markets of both countries.
Implementation of the new Regulatory Framework for In-Vitro Diagnostic Devices
In March 2004, the Australian Health Ministers’ Advisory Council endorsed the key elements of the new regulatory system for in-vitro diagnostic (IVD) devices and the Regulation Impact Statement for this proposal. The TGA has continued to work with stakeholders to develop the draft regulations and a cost model for commercial IVDs. The draft cost model was released to industry in March 2005 for comment. It is proposed to have a staged implementation of the IVD regulatory framework, commencing with commercial IVDs, proposed for implementation in mid 2006 followed by the in-house IVDs regulatory framework. The new regulatory system will bring Australia into line with international best practice for the regulation of IVDs.
Review of Access to Unapproved Therapeutic Goods
The report of the Review of Access to Unapproved Therapeutic Goods commissioned jointly by the TGA and the National Health and Medical Research Council (NHMRC) was completed and accepted by the Clinical Trials Review Steering Committee set up to oversee the project. This review was intended to examine the environment for clinical trial research in Australia and New Zealand and to make recommendations to improve existing systems and to advise on a new system for the Trans-Tasman environment.
The report has since undergone a period of public consultation from 5 April 2005 to 8 July 2005 in order to inform the development of a government response. The TGA encouraged initial submissions from all stakeholders including the community through newspaper advertising and the TGA website. The Government response to the review will guide any required changes to TGA functions prior to the commencement of the Joint Trans-Tasman Regulatory Agency and be reflected in the Trans-Tasman scheme.
Regional Medicines Regulation Support
The TGA hosted in late 2004 the World Health Organization (WHO) Global Training Network (GTN) Course on vaccine regulation for national control authorities and the 10th WHO-UMC Pharmacovigilance - The Study of Adverse Drug Reactions training.
The purpose of the GTN course was to provide training, through interactive workshops, to those countries that require assistance in strengthening their regulation, manufacture and quality control of vaccines. Fifteen participants representing national regulatory authorities and national control laboratories from eight countries participated including China, the Philippines, Vietnam, Egypt, India, Zimbabwe and Nigeria.
Twenty-four participants attended the WHO-UMC Pharmacovigilance course from Australia, Bhutan, China, Fiji, Ghana, Indonesia, Iran, Mongolia, New Zealand, Nigeria, Papua New Guinea, Sri Lanka, Vietnam and Zimbabwe. This representation also included staff from pharmaceutical companies with six being from Australia and one from China. The aim of this course was to support the development of programs for spontaneous adverse reaction reporting.
These programs are increasingly being held in a number of countries around the world. TGA’s involvement in these activities contributes to Australia meeting its international obligations to improve health in developing countries. This is consistent with the Department’s role of providing assistance to strengthen the health systems of developing countries.
Gene Technology Regulation
During 2004-05, the OGTR received a combined total of 66 applications for Dealings involving Intentional Release (DIR) of Genetically Modified Organisms (GMOs) into the environment and Dealings Not involving Intentional Release (DNIR) of GMOs into the environment. At the same time 61 licences were issued. The issuing of these DIRs and DNIRs involved the Regulator preparing a complex risk assessment and risk management plan for each application and then making a decision on each application. In the case of a DNIR and DIR application the statutory response times are 90 days and 170 days respectively. In addition, the Regulator commenced a review of the Gene Technology Regulations 2001, reviewed and updated the Risk Analysis Framework
and was involved in a working group that developed an unintended presence strategy for genetically modified seed imports. Officers from the OGTR also participated in a number of international gatherings on a variety of gene technology issues.
Unintended Presence Strategy for Genetically Modified (GM) Seed in Imported Seed
The OGTR, through its role within the Australian Government’s Working Group on Unintended Presence, has contributed to the development of a whole-of-government strategy to address the possibility of the unintended presence of unapproved GMOs in imported seeds for sowing. The need to develop a strategy stems from the international increase in the uptake of GM technology and the international nature of the seed industry. The strategy combines a number of tools including auditing industry’s existing testing regimes that verify the purity and quality of imported seed, and response plans for crop species identified through risk profiling of imports of seeds for sowing. Following broad consultation by Biotechnology Australia with key stakeholders, including a range of industry and environmental groups, the Biotechnology Ministerial Council has agreed to the strategy and the OGTR, in conjunction with the Australian Quarantine Inspection Service, now has the main responsibility for its ongoing implementation. The strategy will assist in the protection of human health and safety and the environment from the unintended introduction of unapproved GMOs.
The Australian Regulatory Guidelines for Complementary Medicines
The TGA, in consultation with the key Australian complementary medicines industry bodies, the Australian Self-Medication Industry, and the Complementary Healthcare Council of Australia, have developed the Australian Regulatory Guidelines for Complementary Medicines.
The guidelines reflect both the special nature of most complementary medicines and the current Australian requirements for their regulation. It also details TGA regulatory processes and indicates the minimum requirements to demonstrate the quality and safety of complementary medicines. To meet the needs of all stakeholders requiring guidance on the regulation of complementary medicines, the guidelines were structured to provide different levels of detail ranging from broad overviews, to specific technical guidance on the selection and quality of individual studies to support the safety of complementary medicine substances.
Industry representatives fully supported implementation of the guidelines in 2004-05 as a positive measure that clearly articulated the regulatory requirements for complementary medicines.
The OCS, which includes NICNAS, provided advice on potential public health risks posed by chemicals used in the community. In 2004-05, the OCS undertook human health risk assessments and provided toxicological advice to other regulatory authorities on public health issues relating to pesticides, veterinary medicines and industrial chemicals. It also provided technical policy advice on national and international chemicals negotiations and treaties. The OCS compliance program contributed to the National Drug Strategy by implementing controls to deliver the licit end use of scheduled and other controlled substances such as narcotics.
Implemented Key Industrial Chemicals Regulatory Reform Initiatives
During 2004-05, the OCS, including NICNAS, successfully implemented 73 per cent of recommendations arising from the Low Regulatory Concern Chemicals initiative. This included the registration of all persons introducing industrial chemicals into Australia. The remaining 27 per cent of recommendations will be implemented in 2005-06.
In 2004-05, the NICNAS Community Engagement Charter, developed in consultation with the Community Engagement Forum, was established to guide NICNAS’s stakeholder engagement activities. The guidelines for Establishing a Case for Confidential Listing of Chemicals on the Australian Inventory of Chemical Substances
were also published in January 2005.
In 2004-05, the OCS contributed to community protection from the illicit use of controlled substances by monitoring some 1.8 million domestic movements of such substances and completed the integration of public health and occupational health and safety assessments for pesticides and veterinary medicines assessments for the better protection of the Australian community. This represents a 12.5 per cent increase over the 1.6 million domestic movements monitored in 2003-04.