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TGA international engagement strategy 2016-2020
Advancing Australia’s health interests through international engagement
As part of the Department of Health, the Therapeutic Goods Administration (TGA) supports the Department’s strategic priority for an affordable, accessible, efficient and high quality health system through regulation that protects the health and safety of the Australian community, while minimising unnecessary compliance burdens. The International Engagement Strategy 2016-2020 provides an overarching framework to outline the contribution of the Australian therapeutic goods regulator, the Therapeutic Goods Administration (TGA), to international health opportunities and challenges.
This strategy sets three main goals for TGA’s international work:
- contributing to public health and safety through regulation
- working with others to improve the regulatory system
- participation in work sharing and convergence activities.
The strategy is intended to support the Department’s vision statement Better health and wellbeing for all Australians, now and for future generations. It reflects content from departmental documents intended to guide the achievement of this vision, including the 2016-17 Health Portfolio Budget Statements, the Strategic Intent 2016-20, and the Corporate Plan 2016-17.
The strategy outlines how the TGA will:
- continue to pursue Australia’s global health interests through multilateral engagements and country-to-country regulatory partnerships
- keep the product regulation aspects of Australia’s health system at the forefront of international best practice.
- participation in international initiatives to ensure the alignment of international requirements meets acceptable Australian standards of safety, quality and effectiveness
- increased reliance on reports from international regulators used to support Australian regulatory decisions
- greater reliance on post-market signals received from international regulators to trigger appropriate early warnings for the Australian public.
- increasing the use of overseas assessments by comparable regulators, while maintaining sovereignty of regulatory decisions
- increasing flexibility in pre-market assessment processes for medicines and medical devices, including expedited evaluation of particular medicines and devices, provisional approval of certain medicines and allowing the operation of commercial assessment bodies in Australia for medical device assessments
- taking a more risk-based approach to variations to medicines and medical devices and access to products not listed on the Australian Register of Therapeutic Goods (ARTG).
- pre-market assessment
- post-market monitoring and enforcement of standards
- licensing of Australian manufacturers and verifying overseas manufacturers’ compliance with the same standards as their Australian counterparts.
In particular, the TGA will influence international regulatory activity through continued participation in fora such as the International Coalition of Medicines Regulatory Authorities (ICMRA) and the International Medical Devices Regulators’ Forum (IMDRF).
The strategy builds on the 2013-15 strategy through which the TGA advanced a number of objectives including:
Australian Government Response to the Expert Panel Review of Medicines and Medical Devices Regulation
The release of the Australian Government’s response to the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR) in September 2016 sets the agenda for long-term reform of the regulation of therapeutic goods in Australia. The recommendations of the review acknowledged the benefits and efficiencies that accrue from the alignment of international regulatory frameworks as well as the advantages of the increased use of assessments from comparable regulators in reaching regulatory decisions in Australia.
The MMDR also recognised that continued work with overseas regulators to identify suitable opportunities for use of completed assessments as well as work sharing where feasible would help reduce duplication of effort and improve approval timeframes for some products.
The reform agenda for TGA includes:
It is vital the TGA is well-positioned to influence and contribute to the evolving international environment to help support the quality and safety of medicines and medical devices in Australia. This will also enhance the TGA’s ability to promote best practice therapeutic goods regulation while ensuring timely and appropriate access to products to improve health outcomes.
Role of the Therapeutic Goods Administration
Evaluating the safety, quality and efficacy/ performance of therapeutic goods
In its role, the TGA safeguards and enhances the health of the Australian community through effective and timely regulation of therapeutic goods. This includes regulating the supply, import, export, manufacture and advertising of therapeutic goods – legal requirements set out in the Therapeutic Goods Act 1989. The TGA’s approach to therapeutic product vigilance is to continually monitor the safety of therapeutic products and to manage their associated risks.
The international context
Internationally, the TGA is a highly regarded regulator of medicines and medical devices and works closely with the World Health Organization (WHO) and regulatory agencies in comparable health systems. Through active international engagement, the TGA builds on its reputation and expertise by contributing to policies and actions that help advance the health and wellbeing of Australians. Participating in international engagement also helps to fulfil Australia’s responsibility to contribute to improving regional and global public health.
In its international work, the TGA shares information on emerging issues, actively participating in the development of standards and works to align approaches to regulation. The TGA also conducts Good Manufacturing Practice (GMP) inspections to ensure facilities that manufacture products for the Australian market do so in a manner that meets Australian standards.
The TGA regulates therapeutic goods through:
The Expert Panel Review of Medicines and Medical Devices Regulation (MMDR) found that the TGA has a strong reputation as a regulator, both domestically and internationally, and that it benchmarks well against comparable overseas regulators. The MMDR noted the increasing globalisation of the pharmaceutical and medical devices industries and the rapid pace of innovation, and made recommendations as to how to position the TGA to respond to these trends in the future.
Investing in international engagement
Building and maintaining successful relationships with our international regulatory counterparts requires the investment of time and other resources. There are resource and opportunity costs related to preparation for and participation in meetings and conferences, in progressing post-meeting communications and outcomes, and in establishing mechanisms for sharing of product evaluations or safety information.
The return on this investment is progress made in addressing the TGA’s international engagement goals:
- Contributing to public health and safety through regulation
- Working with other countries to improve the regulatory system
- Participation in work sharing, information sharing and regulatory convergence activities.
The benefits that can be realised from increased international engagement include:
- reduced duplication of effort leading to a more efficient and effective regulatory system
- the development of a better understanding of emerging trends and innovations
- access to the latest regulatory science developments
- more informed regulatory decisions for industry
- better safeguards for the Australian community.
How international collaboration can progress work sharing to improve generic medicines regulation
The Australia, Canada, Singapore, Switzerland (ACSS) Consortium Generics Medicines working group is advancing information sharing and work sharing arrangements in the assessment of generic drug applications. A work sharing model based on the European Union Decentralised Procedure is currently being trialed. Its goals are to harness efficiencies in the registration process, promote regulatory convergence of technical data requirements, build confidence between agencies and provide data to be used for the development of a ‘business as usual’ work sharing arrangement.
One of the objectives of the trial is to enable the efficient assessment of the information used in developing a preferred model for work sharing. This trial is consistent with the MMDR recommendations and is an important step in advancing mechanisms which could enable work sharing between comparable medicines regulators from other countries.