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:

1. contributing to public health and safety through regulation
2. working with others to improve the regulatory system
3. 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.

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:

• 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.



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:

• 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).

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:

• 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.

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:

1. Contributing to public health and safety through regulation
2. Working with other countries to improve the regulatory system
3. 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.

Why is this important?

The TGA regulates the import, supply, export, manufacture and advertising of therapeutic goods including medicines, medical devices and biologicals. Since most therapeutic goods originate overseas, it is important that the TGA contributes to international efforts to support the safety, effectiveness and quality of these products.

International engagement helps the TGA maintain an effective regulatory framework that is contemporary and consistent with international best practice. It also assists with proactive post-market monitoring and management of emerging safety and performance issues with particular medicines and medical devices, and staying up-to-date with relevant international standards and conventions.

What are we doing?

The TGA contributes through active engagement in international regulatory initiatives including:

• the International Coalition of Medicines Regulatory Authorities (ICMRA)
• the Heads of Agencies (Australia, Canada, Singapore, and Switzerland (ACSS)) Consortium
• the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) at which the TGA is a formal observer
• the World Health Organization (WHO) and
• the International Medical Devices Regulators Forum (IMDRF).

A comprehensive list of TGA’s engagement with international regulatory initiatives and agencies is listed in the Appendix.

What should we be doing in 2016-2020?

1. Continue to support cooperation, engage and cooperate with the WHO and regulators in comparable health systems.
2. Continue to assist, and work with less advanced regulators in our region to strengthen their capacity.
3. Continue to participate in international regulatory fora, maximising opportunities to improve public health and safety and maintaining our leadership role.

Why is this important?

The TGA is responsible for regulating therapeutic goods to ensure they are safe, effective and of appropriate quality. By increasing efficiencies in regulatory systems and processes, including through engagement with overseas regulators, the TGA will minimise associated regulatory costs on industry.

International engagement provides opportunities for ongoing improvement of our regulatory practice. For example, through examining pre-market processes used by other leading regulators for different types of medicines and medical devices, we can ensure the TGA targets its regulatory efforts and level of regulatory oversight according to the risk of the products.

What are we doing?

The TGA works with international counterparts to improve the quality of the regulatory system. This includes:

• studying approaches and lessons learnt from international regulators for fast tracking approvals processes for certain medicines and medical devices
• exploring how risk assessments and determinations by comparable overseas regulators, as well as international standards can be used more extensively by the TGA when evaluating products.

Consistent with the recommendations of the MMDR, the TGA’s international activities are helping to improve the quality of the regulatory system, including through engagement with international initiatives such as ICMRA, ACSS, IMDRF, ICH, the International Generic Drug Regulators Programme (IGDRP), the International Organisation for Standardisation (ISO), and the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S).

What should we be doing in 2016-2020?

1. Continue to support the MDSAP Regulatory Authority Coalition in a program of ongoing assessment of third party auditing organisations. This will allow the TGA to leverage and have oversight of these audit resources and minimise the duplication of effort for both regulators and medical device manufacturers.
2. Increase flexibility in pre-market assessment / market authorisation processes for medicines and medical devices including those processes used for the recognition of existing QMS assessments that support market authorisation from recognised commercial third parties and other comparable regulatory authorities (e.g. MDSAP, Australian designated third parties).
3. Develop a more comprehensive post-market monitoring scheme for medicines and medical devices which includes enhanced collaboration and the exchange of information with overseas regulators to share information relating to quality, safety and efficacy, or information that supports market authorisation decisions (e.g. MDSAP IT portal based on the Pan American Health Organization (PAHO) Regulatory Exchange Platform).

Why is this important?

Participating in work sharing, information sharing and regulatory convergence activities with comparable international regulators is essential to ensure the TGA continues to make informed and internationally consistent decisions about therapeutic goods in Australia. Work sharing, information sharing and increased regulatory convergence reduce regulatory burden and contribute to provision of a wide range of therapeutic goods for the Australian consumer.

Work sharing, information sharing and regulatory convergence activities help the TGA to:

• identify opportunities to work together with comparable regulators in other jurisdictions, including the potential for work sharing assessments for products marketed in multiple countries to make more informed regulatory decisions about the safety, quality and performance of therapeutic goods available in Australia
• promote the increased use of information from comparable international regulators
• contribute to reducing the effort in pre- and post-market evaluation of therapeutic goods
• assist with timely exchange of information on products that are already on the market
• support the implementation of science-based standards that ensure the safety and quality of products throughout the supply chain.

Such activities also help the TGA build trusted relationships and stay up-to- date on emerging technologies, develop expertise to assist in regulatory decision- making and enable the enhanced use of information technology to support regulatory operations.

What are we doing?

The TGA is actively engaged in work sharing, information sharing and regulatory convergence activities through international initiatives including:

• the Australia, Canada, Singapore and Switzerland (ACSS) Consortium
• the International Coalition of Medicines Regulatory Authorities (ICMRA)
• the International Medical Devices Regulators Forum (IMDRF)
• the International Generic Drug Regulators Programme (IGDRP)
• the International Organisation for Standardisation (ISO)
• Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S).

Enhanced cooperation, including increased reliance on medicines evaluation and facilities inspection information from international regulators, is helping the TGA improve the efficiency of its operations.

Through the implementation of the recommendations of the MMDR, the TGA will provide greater flexibility in approval pathways for medicines and medical devices and respond to areas of regulation where the level of regulation could be more closely aligned with the risk posed by regulated products.

The Australian Government’s response to the MMDR recommendations notes that, in many instances, implementation of work sharing with overseas regulators will only be achievable in the longer term.

What should we be doing in 2016-2020?

1. Continue to actively engage with overseas regulators, as well as with regional and international organisations, to support the implementation of consistent science-based standards that underpin the safety and quality of therapeutic goods throughout the supply chain.
2. Continue to participate in international work sharing, information sharing and regulatory convergence activities to:
   • identify opportunities for Australia to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods
   • develop internationally consistent regulatory requirements
   • contribute to the development of mutual reliance frameworks that reduce regulatory burden on therapeutic goods manufacturers.
3. Provide access for Australian consumers to certain medicines and medical devices that have had evaluations either conducted in part or comprehensively by comparable overseas regulators. This will reduce duplication of effort, leading to efficiencies, while maintaining protection for Australian consumers through oversight by the TGA as the final decision-making authority.
4. Continue to leverage off alerts and pharmacovigilance data from overseas regulators to assist in post-market activities.
5. Look to international best practice to underpin emerging regulatory policy for therapeutic goods.
6. Maintain the close alignment of many areas of medical devices regulation between Australia and the European Union.

TGA’s engagement with international regulatory initiatives and agencies

The TGA has active involvement in many international initiatives and working relationships with several overseas regulators. These collaborations keep TGA well-informed about post-market monitoring of therapeutic goods and ensuring the regulatory framework meets international best practice. The TGA works collaboratively with other overseas regulators on various projects and also has formal collaborative arrangements in place with a number of other regulators.

Details of some of the international regulatory initiatives and agencies with whom the TGA regularly engages include: