Update on compliance verification GMP clearance applications

Common issues with compliance verification GMP clearance applications

5 January 2017

Where recent evidence is available from a recognised overseas regulatory agency, using the equivalent GMP code for the same scope, we may issue a GMP clearance without conducting an on-site inspection via the following pathways:

  • Mutual Recognition Agreements (MRA): ): assessment of a GMP Certificate issued by a country with which Australia has an MRA in relation to the relevant overseas manufacturing site; or
  • Compliance Verification (CV): assessment of a recent GMP inspection report of the relevant overseas manufacturing site prepared by a competent overseas regulatory agency acceptable to the TGA, together with supporting manufacturing documentation supplied by the sponsor or manufacturer.

We receive a large number of GMP Clearance applications via the CV pathway.

We estimate that more than 60% of CV GMP Clearance applications we receive do not provide us with all the required supporting evidence. We contact the applicants to request any supporting evidence which has not been provided with the original application. However, with the number of applications we are receiving (approximately 2000 CV applications per year) this is having a significant impact on our overall processing timelines.

Please note: the information provided here does not replace the requirements specified in the Australian regulatory guidelines Good Manufacturing Practice (GMP) clearance for overseas manufacturers and we strongly recommend that before submitting your application to assure yourself that your application meets all applicable requirements.

We find that one or more of the following documents are commonly not supplied with the CV applications, as required:

  • GMP agreement, when applicable as detailed in Table 1(b)
  • A copy of the most recent inspection report
  • Latest Product Quality Review (PQR), when applicable as detailed in Table 1(b)
  • List of Regulatory Inspections in the last three years
  • Details of regulatory actions within the last three years
  • Manufacturer's declaration for APIs (when not covered during most recent inspection), when applicable

The Australian regulatory guidelines Good Manufacturing Practice (GMP) clearance for overseas manufacturers specifies that Australian sponsors of medicines manufactured overseas have a responsibility to ensure that all required documents are submitted with a GMP Clearance application or this may result in the clearance not being issued.

Please note: manufacturer documents such as Inspection reports and Site Master Files may be sent directly to the TGA from the manufacturer. The TGA prefer to receive electronic copies of documents with clear identifiers, such as application tracking numbers.