TGA international engagement strategy 2016-2020

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13 December 2016

Goal 2: Working with others to improve the regulatory system

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).

Case Study

Medical Device Single Audit Program (MDSAP)

The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonisation. It is a group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory alignment.

The TGA has been actively contributing to the work of the IMDRF, to further a reliance on the output of commercial third party organisations that are capable of conducting Quality Management System (QMS) audits on behalf of regulators. The TGA was an active participant in the IMDRF working group that developed recommendations for a Medical Device Single Audit Program (MDSAP).

The MDSAP was intended to allow recognised auditing organisations to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulatory authorities participating in the program.

Recognising the efficiencies of a single audit that could be used to verify compliance with the regulatory requirements of multiple jurisdictions, a coalition of participating MDSAP regulatory authorities have developed and implemented a comprehensive oversight program that would allow recognised auditing organisations to undertake QMS audits on behalf of regulators in Australia, Brazil, Canada, Japan and the USA.

The program allows the TGA to make a direct contribution to the objectives, processes, competencies and outcomes of third party QMS audits through a collaborative and work sharing arrangement with comparable regulators that promotes regulatory convergence.

The TGA has provided resources for the development of this rigorous program operating under a set of documented controls and practices (MDSAP QMS), and for a contribution to an ongoing program for candidate auditing organisations. A transitional phase will commence in 2017 to align with the introduction of a new version of the relevant standard for manufacturers (ISO13485:2016) and Health Canada’s planned use of the resultant MDSAP certification from 2019.

The TGA is already seeing benefits of participation in the program; for regulatory convergence and for the provision of opportunities for Australian manufacturers to access new markets. The European Union is expected to participate in the program during 2017.

This valuable international collaboration also includes:

  • joint assessments of third party auditing organisations and audits of medical device manufacturers with our overseas partner regulatory authorities
  • sharing of information, reports and manufacturer information
  • the recognition of standards
  • the convergence of regulatory practices.

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).

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