TGA international engagement strategy 2016-2020

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13 December 2016

Goal 3: Participating in work sharing, information sharing and regulatory convergence activities

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.

Case Study

TGA’s involvement in international standards development

Standards are an important cornerstone of good regulatory frameworks, with internationally harmonised standards helping reduce regulatory burden, enhance consumer access to innovative products and avoid technical barriers to trade.

Our microbiologists have participated in the development of international and Australian standards for nearly twenty years. This work is crucial when evaluating, for example, the sterilisation, disinfection, and microbiological aspects of therapeutic goods, with the TGA requiring manufacturer’s adherence to best practices. These practices are specified in standards, which include: Australian/New Zealand standards, European Norms, International (ISO) standards, pharmacopoeial and other industry-based standards.

ISO standards are applicable to both medicines and medical devices. These standards are used by medicine manufacturers to validate and monitor the range of sterilisation processes used during the manufacturing process, and by medical device manufacturers for deeming compliance to the TGA’s Essential Principles or the European Union’s Essential Requirements.

Australia accesses ISO standards development through Standards Australia, and our microbiologists contribute to the technical development of all of the ISO/TC 198 standards that relate to sterilisation of products. The European Pharmacopoeia, British Pharmacopoeia, and United States Pharmacopeia are the TGA’s ‘default standards’ for medicines.

Our scientists contribute to the development of specific pharmacopoeial monographs and general test methods used by the industry and TGA for quality control and medicine release tests, and also hold observer status on a number of European Pharmacopeia Groups of Experts working groups.

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.

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