TGA Updates PRAC Guidance: What Sponsors and Manufacturers Need to Know in 2026

On 24 February 2026, the Australian Therapeutic Goods Administration (TGA) published minor updates and clarifications to its Procedure for Recalls, Product Alerts and Product Corrections (PRAC) .

The PRAC, which replaced the former Uniform Recall Procedure for Therapeutic Goods (URPTG) in March 2025, continues to define how sponsors must conduct market actions in Australia.

While the latest changes are described as minor, they introduce important clarifications that manufacturers and sponsors should carefully review — particularly those supplying medical devices, medicines, biologicals, or consumer-facing therapeutic goods in Australia.

Background: PRAC Replaced URPTG

The PRAC came into effect on 5 March 2025, replacing the URPTG .

Although largely a structural rewrite, the PRAC introduced several key procedural refinements:

• Replacement of the “recall” vs “non-recall” distinction with the broader term “market actions”

• Reduction of the recall process from 10 steps to 5

• Simplified classification system (Class I, II, III)

• Greater transparency around the Early Advice process

• Flexible reporting requirements

• Introduction of updated TGA templates

• Removal of TGA verification of sponsor customer lists

The February 2026 update introduces additional clarifications and structural improvements.

What Was Updated in February 2026?

According to the TGA page history, updates include :

• Clarification of the timeframe for notification under Immediate Actions

• Amendment of the “Purpose” section

• Addition of a new graphic clarifying what constitutes a “problem”

• Renaming and minor revision of the section addressing:

  • High-profile actions

  • Actions involving untraceable products

• Minor wording updates to definitions of:

  • Recall

  • Product Correction

• Clarification regarding who may perform a product correction/repair

• Additional requirements concerning exported goods

• Amendments to the section on wholesalers and distributors

• Addition of new sections:

  • TGA legislative powers relating to market actions

  • Frequently Asked Questions (FAQs)

• Minor editorial changes across the document

These adjustments do not change the fundamental process, but they do refine expectations and compliance responsibilities.

Immediate Actions: Clarified Expectations

The TGA clarified the notification timeframe for Immediate Actions, which apply to situations involving:

• Imminent or significant risks to patient lives or public health

• Suspected tampering

• Radiopharmaceuticals

• Blood or biological products

• Clinical trials

Sponsors must notify customers immediately (before TGA review) in urgent cases and contact the TGA within 48 hours .

Impact for manufacturers:
Companies must ensure their internal escalation procedures allow for rapid quarantine, communication, and regulatory notification within tight timeframes.

No More TGA Verification of Customer Lists

One of the most operationally significant changes retained under PRAC is that the TGA:

No longer verifies the accuracy of sponsor customer lists

Sponsors are now fully responsible for:

• Submitting accurate customer lists

• Using correct TGA templates

• Avoiding delays due to incomplete information

Impact:
Manufacturers must ensure distribution traceability systems are robust. Poor record-keeping may delay recall approval or lead to regulatory scrutiny.

This aligns closely with ISO 13485 traceability expectations for medical devices.

Increased Transparency: Early Advice & Public Communications

The PRAC formalizes the Early Advice Notice process, allowing TGA to alert state and territory recall coordinators or professional bodies before formal agreement .

Additionally, high-profile or untraceable consumer-level actions may require:

• Public notices

• Website announcements

• Retail notices

• Social media communications

Impact:
Manufacturers should prepare crisis communication strategies in advance. Public visibility of recalls is increasing through:

• DRAC (Database of Recalls, Product Alerts and Corrections)

• TGA web statements

• Stakeholder notifications

Reputational risk management must now be considered part of recall preparedness.

Reporting and Closeout: Stricter Follow-Up Expectations

Sponsors must submit:

• An interim report at 6 weeks

• A closeout report at 12 weeks

If reports are incomplete or repeatedly inadequate, the TGA may use its legislative powers to compel submission of information .

The February 2026 update also introduced a dedicated section on legislative powers relating to market actions .

Impact:
Manufacturers should ensure:

• Root cause investigations are documented

• CAPA timelines are realistic

• Non-responder follow-up attempts are recorded (minimum three attempts required)

• Overseas supply notifications are managed within statutory timeframes

Interaction with ACCC – Lead Regulator Clarified

The PRAC reiterates that when a therapeutic good is also a consumer good, the Australian Competition and Consumer Commission (ACCC) may be the lead regulator in cases involving:

• Non-compliance with product bans

• Non-compliance with mandatory safety standards

Sponsors must notify the ACCC within 2 days of initiating a market action when applicable .

Impact:
Manufacturers of consumer-facing devices (e.g., diagnostic kits, home-use devices, PPE) must assess whether dual regulatory notification applies.

Strategic Considerations for Manufacturers

Although described as minor, the 2026 updates reinforce key regulatory expectations:

• Speed of response

• Traceability accuracy

• Clear risk classification

• Structured reporting

• Public transparency

• Alignment between sponsor and manufacturer responsibilities

Manufacturers supplying Australia should verify that their QMS:

• Clearly defines recall responsibilities

• Aligns with ISO 13485 (medical devices) and ISO 14971 risk management

• Includes mock recall testing

• Covers export and consumer-law obligations

• Integrates ACCC notification triggers where applicable

Final Takeaway

The PRAC remains structurally stable, but the February 2026 refinements confirm that the TGA expects:

• Greater sponsor accountability

• Higher documentation quality

• Faster escalation

• More transparent public communication

For manufacturers operating globally, alignment between EU MDR, UK MHRA recall requirements, and Australian PRAC procedures should be part of regulatory strategy planning.

Read the full document below.