TGA (Australia) Approaches for Accelerated Medicine Approvals

Duration: 22 minutes


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Why watch


The time taken to obtain regulatory approval is a key focus for pharmaceutical companies, regulatory agencies and patients alike, with shorter evaluation times leading to increased “sales under the curve” and earlier access for patients to new treatments. As a key focal point, regulators are not only benchmarking their performance with their international counterparts but are now actively collaborating on regulatory evaluations. For the relatively smaller regulatory agencies such as Australia’s Therapeutic Goods Administration (TGA), this represents a great opportunity to leverage this globalization to accelerate market access.
In the past, the TGA required new prescription medicine applications to undergo a comprehensive de novo quality, safety and efficacy assessment, irrespective as to whether a similar application had already been approved by comparable regulatory agencies such as the EMA, the USA FDA of Health Canada.  Furthermore, there was only one regulatory pathway with a standard evaluation timeline of 255 working days for achieving approval.  In recent times, the TGA has introduced a range of new prescription medicine application pathways that utilize overseas evaluations and accelerate market access. These new pathways embrace a wide range of initiatives, both locally focused (e.g. the introduction of a priority review process for breakthrough medicines) and internationally (e.g. reduced evaluation and truncated timelines for applications that have recently been approved in a comparable jurisdiction).  The TGA has also been actively involved in global regulatory initiatives that focus on regulatory efficiency and accelerated patient access, being an included company in the FDA’s Project ORBIS, and is a founding member of the Access Consortium (ACSS), a work -sharing-collaboration between various regulatory bodies including Singapore, Switzerland, and the UK.
This webinar presents the TGA’s recent application process changes and outlines how local and international pharma companies can leverage these pathways to truncate regulatory approval timelines in Australia, reduce the regulatory resource burden for supporting evaluations, and accelerate patient access.  

Key Learnings

  •  Following international approvals in territories such as the Europe, Canada and Japan, the TGA’s Comparable Overseas Regulator (COR) pathways can reduce Australian approval time by >50%
  •  By utilizing the Access Consortium, the regulatory evaluation for new medicines can be shared across jurisdictions, minimizing duplication of effort from the regulators and resource challenges at company head office.
  •  TGA’s participation in the FDA ORBIS initiative and the introduction of a priority review process creates a rapid approval pathway for oncology and breakthrough medicines.
  •  The introduction of a provisional approval pathway enables applicants to obtain Australian regulatory approval on early phase data thus avoiding patient access delays while awaiting confirmatory clinical data.

A full hour of inspirational speaker(s)

Rob Stringer

Principal Consultant

Robert has more than 25 years of experience in the Australian and New Zealand pharmaceutical industry.

Prior to establishing Capital K Consulting, Robert was a member of the leadership team at AstraZeneca Australia, having managed the Regulatory Affairs, Clinical Research and Strategic Planning & Business Development teams. His career also includes the green fields market entry into Australia of Sandoz (the generic arm of Novartis), ultimately holding the role of Research and Development Manager. In this role his responsibilities included leading the regulatory, product development, and quality assurance functions, along with joint leadership of the product sourcing and partnering arrangements. At Sandoz, Robert achieved the world-first market approval of a biosimilar.

Robert is an active supporter of the industry. His deep engagement with professional associations includes the provision of pharmaceutical training programs to Australian Association of Regulatory and Clinical Scientists (ARCS) and participation in the Regulatory Affairs Professionals Association (RAPS).