By Esh Tadiyal, Principal Consultant (DDC), Novotech, and Renita Hite, Director, Regulatory Affairs (DDC), Novotech

Australia has taken a significant step toward strengthening national public health infrastructure with legislation establishing a permanent, independent Australian Centre for Disease Control (CDC), that went into effect 1 January 2026. This development reflects the lessons of COVID-19 and subsequent health events, and signals a long-term commitment to coordinated preparedness, evidence-informed decision-making, and improved health system resilience.

While the Australian CDC will not function as a regulatory authority, its establishment is expected to influence the clinical research environment. For sponsors, investors, and global biotech leaders evaluating Australia as a clinical trial destination, a national CDC points to stronger disease surveillance, data modernization, and more consistent public health risk management. Over time, these factors may support more predictable trial planning and execution, particularly for communicable and occupational diseases.

Why the Australian CDC matters for clinical research sponsors

The CDC’s mandate is centered on public health intelligence and emergency preparedness. As these capabilities mature, clinical research stakeholders may benefit from improved visibility into disease burden and population trends, as well as a clearer national approach to outbreak response and data coordination.

For clinical development programs, the potential value is practical:

  • Stronger inputs for feasibility and site selection, supported by more timely epidemiology and surveillance data
  • Better-informed protocol design and risk assessment, including geographic clustering and patient population insights
  • Improved continuity of site operations during infectious disease events, reducing disruption risk for ongoing studies
  • Expanded opportunities to incorporate real-world evidence (RWE) into evidence plans, supporting both development and commercialization strategies
  • A more stable foundation for hybrid evidence generation that aligns clinical outcomes with public health insights

Benefits for researchers and trial sites

Beyond sponsor decision-making, a national CDC can also bring practical advantages for investigators, research teams, and trial sites—particularly those operating in infectious disease, occupational health, and other public health-relevant programs.

Potential benefits include:

  • More consistent access to public health intelligence that can inform study rationale, endpoints, and patient population selection
  • Improved situational awareness during outbreaks, supporting continuity planning and patient safety oversight at the site level
  • Better alignment between research priorities and emerging public health needs, which may strengthen study relevance and stakeholder engagement
  • Increased opportunities for collaboration across jurisdictions, including coordinated approaches to surveillance-informed research questions
  • More robust context for interpreting clinical outcomes and safety signals, particularly when disease patterns shift over time

For investigators, these advantages may translate into stronger study planning, clearer operational assumptions, and improved resilience during periods of public health disruption.

Strengthened national disease surveillance

A core function of the Australian CDC is to consolidate and strengthen public health intelligence across communicable and occupational diseases, emergency preparedness, and response to public health threats. For sponsors and clinical research teams, this may translate into a more robust national data environment to support trial planning and ongoing oversight.

Potential implications include:

  • More consistent monitoring of emerging health trends and safety signals
  • Improved access to public health intelligence for feasibility, enrollment planning, and operational risk management
  • Better-informed decision-making during trial execution, particularly in infectious disease settings

Enhanced predictability across jurisdictions

Australia’s public health responsibilities are shared across the Commonwealth, states, and territories. Historically, this structure has created variability in public health responses and data coordination across jurisdictions.

Although the CDC does not replace research governance processes, its national role may help reduce uncertainty for studies impacted by infectious disease dynamics by:

  • Harmonizing outbreak intelligence at a national level
  • Supporting access to real-time outbreak and surveillance data
  • Reducing jurisdictional variability in public health response approaches
  • Helping sites plan for operational continuity during communicable disease events
  • Improving forecasting and planning for researchers

For global sponsors, this may strengthen Australia’s positioning as a reliable environment for clinical trials in communicable diseases and public health-relevant programs.

What this could mean for industry

As the CDC becomes operational and its systems mature, sponsors may see practical benefits across multiple aspects of clinical development:

More informed feasibility and site strategy

Improved national data infrastructure could enhance feasibility assessments and support faster, more accurate trial planning.

A clearer national narrative for global biotechs

A national CDC can reinforce the perception of strong governance and long-term predictability, important for emerging biotech and first-time entrants to Australia.

Better evidence alignment across stakeholders

Over time, closer alignment across public health priorities, clinical development evidence, and downstream reimbursement strategies may support stronger market planning.

Novotech perspective: what we are tracking

Novotech is monitoring how the CDC’s operating model evolves and what it may mean for sponsors and researchers running trials in Australia, including:

  • How surveillance and epidemiological data will be shared and accessed
  • Data access frameworks and governance mechanisms
  • How the CDC will interact with the Therapeutic Goods Administration (TGA), Human Research Ethics Committees (HRECs), and jurisdictional governance structures

Importantly, the legislation provides for a review to be conducted in 2028. As part of that review process, the CDC’s scope may be assessed, and—depending on the outcomes and the CDC’s evolving remit—there may be future consideration of extending beyond infectious diseases to areas such as non-communicable and chronic diseases.

What sponsors should do now

Sponsors planning clinical trials in Australia—particularly in communicable and occupational diseases—should consider the CDC’s establishment in near-term planning. Practical steps include:

  • Evaluate Australia early across clinical trial phases for relevant indications, including Phase III and public health-relevant programs
  • Consider how national data frameworks may strengthen feasibility, protocol design, and operational continuity planning
  • Monitor policy updates and implementation guidance as the CDC becomes operational
  • Engage CRO partners with active regulatory and operational tracking to support informed decision-making

Looking ahead

The establishment of Australia’s CDC is a major milestone in national public health strategy. Within the scope of current legislation, it is expected to strengthen intelligence in communicable and occupational diseases, enhance emergency preparedness, and support greater operational predictability during public health events. These shifts may also improve feasibility, start-up planning, and continuity for clinical trials in relevant therapeutic areas.

Long-term impact will depend on how the CDC’s operational framework develops, including the findings of the legislated 2028 review. The direction is clear: stronger coordination, better data infrastructure, and improved preparedness—all of which matter to sponsors and researchers executing clinical research in Australia.