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In Australia, GMP Clearance (Good Manufacturing Practice Clearance) is a mandatory requirement for all overseas manufacturers supplying medicines and certain biological products to the Australian market. Issued by the Therapeutic Goods Administration (TGA), GMP Clearance ensures that manufacturing sites comply with internationally recognized quality standards before products can be included in the ARTG (Australian Register of Therapeutic Goods).

Unlike many regulatory authorities that rely solely on local inspections, the TGA follows a hybrid, risk-based approach that allows manufacturers to demonstrate compliance through multiple pathways, including:

  • Mutual Recognition Agreements (MRAs) with trusted regulators
  • Certificates of GMP Compliance issued by comparable authorities (EU, UK, Canada, Japan, etc.)
  • TGA-conducted on-site inspections
  • Desktop audits (evidence-based assessments)

The type of clearance required depends on product category, risk classification, and the level of regulatory oversight in the country where manufacturing occurs.

To obtain GMP Clearance, sponsors must submit comprehensive evidence packages covering:

  • Quality system certifications
  • Manufacturing process details
  • Inspection history & audit outcomes
  • CAPA documentation
  • Validation and quality records

The TGA evaluates these materials to determine whether the facility meets Australia’s stringent GMP standards.

Without valid GMP Clearance, no product manufactured overseas can be released to the Australian market.

As global regulatory expectations rise and reliance models evolve, GMP Clearance has become a critical compliance milestone for pharmaceutical manufacturers seeking timely market access in Australia.

Partner with Freyr Solutions for GMP Clearance & Australia Regulatory Compliance

Freyr’s Regulatory Affairs experts support end-to-end TGA and ARTG requirements, including:

  • GMP Clearance application preparation
  • Evidence package compilation & QC
  • CAPA justification & documentation support
  • eCTD publishing & ARTG dossier submissions
  • TGA liaison & lifecycle management

Contact Freyr Solutions today to streamline your Regulatory Affairs operations and accelerate your market entry into Australia.