TGA Compliance Principles 2026–27: Priority Focus Areas to 31-MAR-2026

 In Australia’s ever‑evolving healthcare landscape, regulatory priorities are generally dynamic. The focus of regulators inevitably shifts in response to evolving technologies, emerging public health risks, changing consumer behaviours and increasingly complex global supply chains. As regulated industries continue to transform over time, regulators must adjust their compliance-enforcement strategies to remain effective, relevant and risk-based.

In line with this, the Therapeutic Goods Administration (TGA) has re-aligned its approach. The TGA Compliance Principles for 2026–2027 focus on five core compliance principles, each supported by routinely reviewed priority focus areas¹. These principles guide compliance and enforcement activities across organisations involved in the import, export, manufacture, supply and advertising of therapeutic goods in Australia.

At a high level, the Compliance Principles reflect a more proactive, risk-based and timely regulatory posture.

The Five Core Compliance Principles for 2026–2027

1. Safeguarding Therapeutic Goods

   • Ensuring protection from unsafe or non-compliant products while increasing transparency and visibility of regulatory actions to the public.

2. Educating to Empower

   • Actively engaging with industry, healthcare professionals and consumers through guidance, outreach and education to promote sustainable compliance.

3. Protecting Those Most at Risk

   • Prioritising regulatory interventions that protect vulnerable populations through adaptive, targeted and intelligence-led strategies.

4. Leveraging Digital Capability

   • Enhancing digital monitoring and data analytics capabilities to address rising technological risks and digital health innovations.

5. Strengthening Enforcement

   • Improving public and industry confidence through visible and decisive enforcement actions where non-compliance is identified.

Priority Focus Areas from 1 January 2026 to 31 March 2026

Supporting the five Compliance Principles, the TGA has identified specific therapeutic product categories that are subjected to heightened regulatory scrutiny in the first quarter of 2026.

1. Direct-to-consumer in vitro diagnostic (IVD) kits

2. Erectile dysfunction medications

3. Foetal dopplers

4. Listed medicine advertising

5. Medicinal cannabis

6. Melatonin

7. Software as a Medical Device (SaMD)

8. Substandard and falsified therapeutic goods

9. Sunscreens

10. Weight loss medications

11. Therapeutic goods used in cosmetic procedures

12. Vaping goods

SeerPharma supports a diverse group of clients in regulated industries with advice and guidance across a range of compliance activities. Some of the precent projects helping clients in these TGA focus areas are described in this blog.

Software as a Medical Device (SaMD)

With the rapid expansion of digital health platforms, AI-driven diagnostics and software-based clinical tools, regulatory expectations for SaMD continue to grow. These specific software products present unique challenges around clinical validation, cybersecurity, data integrity and lifecycle management.

Sponsors and manufacturers of SaMD (standalone software that intends to deliver a clinical functionality without being part of a physical medical device) should expect close scrutiny in areas such as:

• Correct classification and ARTG inclusion

• Robust clinical validation and performance evidence

• Demonstrated safety, risk management and regulatory compliance

• Effective change management for software updates

• Ongoing post-market surveillance and monitoring

A notable challenge within this sector is that many software developers have only recently entered the medical device domain. While technically sophisticated, these organisations may lack the familiarity and expertise with regulated industry requirements such as ISO 13485-aligned Quality Management Systems, design controls, risk management and validation framework. Bridging this regulatory knowledge and experience gap is critical to achieving and maintaining compliance.

As part of SeerPharma’s consulting engagements, we have supported numerous software developers transitioning into the regulated medical device space. Our involvement spans from Quality System gap assessments, QMS implementation and remediation, computer systems validation, and regulatory readiness activities across various stages in the software development lifecycle.

Vaping Goods

With recent updates to TGA standards for vaping devices, there is more regulatory oversight and increased compliance requirements for manufacturers and sponsors looking to import vapes and vaping accessories into Australia.

Sponsors and manufacturers of vaping goods should anticipate regulatory scrutiny in areas including:

• Supply chain compliance and traceability

• Adherence to prescription and pharmacy-only pathways

• Lawful importation and authorised supply

• Compliance with advertising restrictions

• Product standards, labelling and ingredient controls

Due to the heightened sensitivity surrounding youth access and illicit supply channels, enforcement actions in this area required to be ever more visible. Organisations operating in this space must ensure strong governance, documented compliance controls and ongoing monitoring of post-market surveillance.

Recently, SeerPharma has supported clients looking to import vaping devices, ensuring they are compliant with the new standards and that the company continues to meet TGA requirements for the supply of these devices to market.

Direct-to-Consumer In Vitro Diagnostic (IVD) Kits

The expansion of self-testing kits, including those for infectious diseases, genetic screening and chronic condition monitoring has intensified regulatory attention from TGA.

These products are supplied directly to consumers without healthcare professional mediation, raising the bar of scrutiny for improving clarity, usability and risk communication. Therefore, sponsors and manufacturers of IVD kits should anticipate regulatory scrutiny on:

• Substantiated clinical performance claims

• Clear labelling and comprehensive user instructions

• Appropriate risk communication to users

• Advertising compliance and avoiding misleading claims

Organisations must ensure that these products meet robust performance, safety and usability standards, particularly given the potential public health implications of incorrect self-interpretation of clinical test results.

Lately, SeerPharma has supported several IVD kit manufacturing clients with their QMS implementation and optimisation, conducting internal audits, overseeing compliance, Quality System remediation activities, and external audit preparations.

Ongoing Compliance and Industry Implications

The TGA has indicated that it will conduct quarterly reviews of these priority focus areas to support the 2026-2027 Compliance Principles.

If your organisation is looking to proactively assess or address known concerns with quality system elements, design controls, validation frameworks and strategies, process controls, or other compliance activities, SeerPharma has experienced subject matter experts to assist.

Contact us to explore your needs and how we can help.

1. Compliance Principles 2026 and 2027 | Therapeutic Goods Administration (TGA)