The increasing prevalence of antimicrobial‑resistant (AMR) bacterial infections has renewed interest globally in bacteriophage therapies — that is, the use of viruses that specifically infect and lyse bacterial cells. In Australia, the regulatory body Therapeutic Goods Administration (TGA) is now actively consulting on a time‑limited exemption from Good Manufacturing Practice (GMP) requirements for certain personalised bacteriophage therapy products (BTPs). For manufacturers, therapeutic goods producers, testing laboratories and biotechnology companies operating under GMP/regulatory‑compliance regimes (such as those served by Quality Systems Now), this development presents both an opportunity and a regulatory risk. In this paper‑style blog post we examine the regulatory context, scope and implications of the proposed exemption, and key quality‑system considerations for stakeholders.

Regulatory Context and Rationale

The TGA’s consultation document outlines that although bacteriophage therapy has potential to address AMR and device‑related infections, no phage products are currently approved in Australia and no GMP‑licensed phage manufacturing facilities exist domestically. As a result, access to phage therapies is primarily through the Special Access Scheme (SAS), Authorised Prescriber (AP) scheme or clinical trial notification (CTN) pathways.

To support industry development while safeguarding quality and patient access, the TGA proposes an amendment to the Therapeutic Goods Regulations 1990 to allow a temporary exemption from manufacturing‑licence/GMP requirements under Part 3‑3 of the Act, for personalised and small‑batch bacteriophage manufacture.

The rationale is two‑fold: (1) to avoid impeding access to bespoke phage therapies by forcing importation or delayed manufacture; and (2) to allow time for domestic manufacturers to upgrade facilities, build data, and apply for full GMP licences in a regulated, transparent manner.

Scope of the Exemption and Key Criteria

Under the proposed exemption, the following elements are relevant:

• The exemption is time‑limited and applies to manufacturers of personalised and small‑batch BTPs only.

• It covers manufacture where a full‑scale GMP manufacturing licence is not yet held.

• The exemption does not mean elimination of all regulatory obligations: products remain unapproved therapeutic goods, requiring pathways such as SAS/AP/CTN for patient access.

• The exemption is intended to be a bridge while the sector develops manufacturing standards, clinical evidence and regulatory infrastructure.

For manufacturers and labs this means stringent oversight is still required: even under an exemption the principal sponsor/manufacturer remains responsible for ensuring product quality, safety‑risk assessment, and compliance with essential manufacturing and documentation principles (even if formal GMP licence is not yet held).

Implications for Quality Systems and Compliance

From the perspective of GMP and regulatory compliance, several key implications must be addressed by manufacturers, contract manufacturers, testing laboratories and biotechs:

Manufacture and process validation

Even if an exemption is in place, the manufacturing of phage therapies must satisfy robust quality‑system controls. Critical aspects include phage characterisation, bacterial host/debris clearance, sterility/asepsis, potency assays, impurity/ endotoxin analysis and stability testing. Given the novel nature of phage therapies, processes may be less standardised and more custom‑designed — emphasising the need for clearly documented validation, risk assessments and change‑control systems.

Documentation and traceability

Quality systems must incorporate full traceability of starting materials (bacterial strains/hosts), phage lots, manufacturing batches, quality control results, and release criteria. Even in a small‑batch personalised context, deviations, non‑conformances, complaints and adverse events must be captured and managed. The exemption does not remove responsibilities for adverse‑event reporting or supplier oversight under the Therapeutic Goods Act 1989.

Regulatory preparedness and transition planning

Manufacturers should view the exemption as transitional. That means planning early for full GMP‑licensing, or equivalently robust compliance, including site audits, vendor qualification, facility/clean‑room design, environmental monitoring, and periodic inspections. Regulatory submissions may require pre‑submission meetings with TGA (particularly for advanced therapies) to clarify evidence expectations.

Risk‑management focus

Given the bespoke nature of individualised phage therapies, risk‑management frameworks must be strong. This includes risk assessment of microbial contamination, phage resistance emergence, unintended cross‑contamination, and patient safety/efficacy. Documentation of risk‑mitigation strategies must feed into quality‑system governance, change control and continuous improvement programs.

Testing laboratories and analytics

For labs supporting phage manufacturers, there are implications for method validation, quality control competence, sample chain‑of‑custody, calibration and qualification of equipment, and alignment with GMP or GMP‑like standards. Even if the manufacturer holds an exemption, the upstream and downstream testing work needs to align with high standards to support regulatory submissions and traceability.

Risks and Considerations for Manufacturers

While the exemption presents flexibility, manufacturers must remain alert to a number of risks:

• The exemption is temporary and subject to regulatory revision. Failure to transition to full GMP compliance could lead to regulatory censure or manufacturing‑disruption.

• Misinterpretation of the exemption could lead to insufficient quality practices; regulators may still audit or inspect processes inconsistent with the spirit of GMP.

• Importation or export of BTPs may raise additional regulatory obligations (including overseas GMP equivalence, import licence requirements or ARTG listings) beyond the exemption scope.

• If the product moves from personalised/small‑batch to broader commercial scale, the exemption may no longer apply and full GMP licencing will be required.

• Stakeholder assurance (clinicians, hospitals, patients) will still demand transparency of manufacturing, quality control and safety data — so quality systems must reflect best practices even under interim regulatory allowances.

Strategic Recommendations for Quality Systems Now Clients

For clients of regulatory‑compliance specialists such as Quality Systems Now (therapeutic goods manufacturers, testing laboratories, biotech companies) the following strategic steps are advised:

1. Identify eligibility: Assess whether your phage therapy manufacture qualifies for the exemption (personalised/small‑batch, under SAS/AP/CTN) and clarify applicable regulatory pathways with TGA.

2. Gap analysis: Conduct a detailed gap‑analysis comparing your current quality system against full GMP standard (including facility design, equipment qualification, documentation, personnel training, change control and deviation management).

3. Risk management plan: Develop a risk‑management framework specific to phage manufacture, addressing microbial safety, host/phage characterisation, cross‑contamination prevention, traceability and patient‑safety monitoring.

4. Plan transition to GMP: Prepare a roadmap for scaling processes, securing manufacturing licence, upgrading systems and aligning with inspection expectations. Include timelines, budget and training.

5. Engage testing laboratories early: Ensure analytical labs used are qualified, validated and have documented quality systems that integrate with your manufacturing process. Consider contracting audits or vendor assessments.

6. Maintain robust documentation: Even under exemption, maintain full batch records, deviation logs, change control, validation master plans and release records. Prepare for eventual regulatory submission or audit.

7. Stay current with TGA developments: The consultation closes 13 November 2025. Monitor TGA’s final amendments and implement any regulatory changes as they arise.

Questions? Talk to us today

The proposed temporary GMP exemption by the TGA for personalised bacteriophage therapy manufacture in Australia marks a significant regulatory development for the emerging phage‑therapy sector. It offers a valuable window for manufacturers, testing laboratories and biotech firms to innovate while aligning with regulatory frameworks. However, it is not a release from compliance or quality responsibilities — indeed, a robust quality system, rigorous documentation, advanced risk controls and strategic transition planning are essential. For organisations served by Quality Systems Now, this is an opportune moment to strengthen quality‑system readiness, ensure regulatory alignment, and position for future scalability under full GMP compliance.

By appreciating the regulatory context, understanding the scope of the exemption, and proactively addressing the compliance implications, therapeutic‑goods manufacturers, testing labs and biotech enterprises can capitalise on this regulatory accommodation without compromising on quality, safety or regulatory integrity.