Over time, there have been huge developments in medicines and biologics sectors, and so have the changes in their respective Regulatory regimes and manufacturers’ responsibilities. On similar lines, recently, the TGA issued guidance describing the responsibilities of manufacturers of medicines and biologics. It is a step-by-step guide for:

  • Australian manufacturers of therapeutic goods (medicines, active pharmaceutical ingredients (APIs) and biologicals, human blood and blood components, and haematopoietic progenitor cells) applying for a manufacturing license for an Australian manufacturing site.
  • Australian sponsors of therapeutic goods manufactured overseas, applying for GMP certification of the overseas manufacturer.
  • Overseas manufacturers inspected by the TGA.

As per the guidance, a manufacturing license can only be obtained for the Australian manufacturing sites, and the overseas manufacturers can instead obtain GMP certification following a successful on-site inspection by the TGA. The Australian sponsor or an agent acting on behalf of the Australian sponsor is required to submit the GMP certification applications. GMP certification is usually only requested if it is not possible to obtain GMP clearance via the Mutual Recognition Agreement (MRA) or Compliance Verification (CV) pathways, for example, due to lack of evidence. The TGA reserves the right to undertake an inspection of an overseas manufacturing site irrespective of the evidence provided.


The guidance states that both manufacturers and sponsors need to be aware of the following responsibilities.

Manufacturers Responsibilities

Comply with principles, standards, and conditions

  • While manufacturing, observe the applicable manufacturing principles
  • Ensure that the manufactured goods conform to any applicable standards
  • As communicated and agreed to by the TGA, implement any CAPA plans to rectify deficiencies
  • Observe any conditions, restrictions, and authorizations of the license or certification and do not undertake manufacturing contrary to these limitations

Keeping Records

  • Of the materials used in manufacturing goods, the supplier and quantities of the materials used, and details of the tests performed on those materials
  • Of the procedures and controls employed while manufacturing goods
  • Of the test details performed on the goods and their results
  • Of the stability studies, if any

Sponsor Responsibilities

Before Submission, while drafting applications, ensure that

  • The scope of the application is relevant to the activities carried out by the manufacturing site and is reflected in the evidence provided
  • All the information provided in the application is accurate and does not contradict the corresponding information contained within the evidence provided
  • All required evidence is attached when submitting the GMP certification or clearance application or provided to TGA directly by the manufacturer
  • For GMP clearance applications, the signed and effective GMP/Quality/Technical agreements are in place and meet the relevant requirements, if required

During processing, when under review, ensure that

  • Any additional information or clarification requested by the TGA during the assessment of GMP certification or clearance applications are provided within the specified timeframe
  • Any updated evidence that becomes available while the application is under review is provided to the TGA

Post-approval, after active GMP clearance, ensure that

  • The Regulatory actions by any competent overseas Regulatory authority (for example, recalls, unacceptable inspection findings, warning letters, import alerts, etc.) for manufacturing sites for which you hold an active GMP clearance are monitored
  • The GMP/quality /technical agreements with your manufacturer are maintained
  • Any Regulatory actions or any significant changes to the manufacturing site, quality management system (QMS), products, or product range, where the changes could potentially impact the GMP compliance of the site, should be notified to the TGA
  • For renewal of a GMP clearance, you must submit applications at least six (06) months before the expiry of the current clearance, or, if evidence for a renewal is not available, request TGA certification

Henceforth, to achieve compliance, the manufacturers of medicines and biologics must ensure to abide by their respective responsibilities. To avoid any procedural bottlenecks, consult a (G)local Regulatory partner like Freyr. Stay informed. Stay compliant.


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