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For pharmaceutical and medical device companies entering the Australian market, getting a product approved by the Therapeutic Goods Administration (TGA) is a major milestone — but it’s far from the finish line.

That’s where Lifecycle Management (LCM) comes in.

Lifecycle Management in the TGA context refers to the ongoing regulatory activities that ensure a product remains compliant throughout its time on the market. Once included in the Australian Register of Therapeutic Goods (ARTG), every change to the product — be it formulation, labeling, manufacturing site, or packaging — must be managed in accordance with TGA’s defined post-approval frameworks.

This includes:

  • Variations: Managing major and minor changes (Category 1, Category 3, or self-assessable).
  • Renewals: Maintaining valid GMP clearances and periodic license updates.
  • Post-approval updates: Keeping CMC data, labeling, and safety information current.

Effective lifecycle management ensures sustained market access, regulatory compliance, and patient safety. It also minimizes the risk of ARTG suspension or product recall — critical for maintaining business continuity.

In a rapidly evolving regulatory landscape, a proactive post-approval strategy is no longer optional; it’s essential.

Freyr’s Australia office supports global and local companies in building compliant, efficient LCM frameworks aligned with TGA and ICH standards. From dossier variations to renewal management and labeling updates, Freyr ensures your compliance never lapses.

Read the full article: Lifecycle Management & Post-Approval Strategy: Sustaining TGA Compliance in Australia’s Pharma Market