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GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic

3 July 2020

The COVID-19 pandemic has created many challenges to the ongoing Good Manufacturing Practice (GMP) regulation of medicine and biological manufacturers.

Following the suspension of overseas GMP inspections and QMS audits, a significant amount of consideration was given to the appropriate level of regulatory oversight required to maintain an assurance of product quality without requiring wholesale changes to existing processes.

These considerations needed to be agile yet sustainable as the length of time that international travel restrictions remain in place is difficult to predict.

Remote GMP Inspections

Manufacturers of medicines and biologicals are routinely inspected using a risk-based approach against the appropriate Manufacturing Principles.

Following the suspension of on-site inspections, we developed new arrangements to allow continued and flexible oversight of licenced domestic manufacturers by performing remote GMP inspections.

The domestic program demonstrated that it would be possible to replicate this approach for overseas medicine and biological manufacturers. However, it is recognised that broadening this program may bring additional challenges and the same number of manufacturers cannot be inspected using this approach.

From July 2020, we will begin the remote GMP inspections program for some overseas manufacturers.

Sponsors who have submitted Certification (CE) applications or whose manufacturer has been identified as requiring a remote GMP inspection will be contacted to register their interest in participating.

We have published additional guidance on the Expectations for overseas manufacturing sites hosting remote inspections during the COVID-19 pandemic.

As travel restrictions begin to ease, we may still conduct on-site components of GMP inspections of manufacturers who have had a remote inspection performed.

GMP clearance

We are conscious that a number of our overseas regulatory partners have also faced disruptions to their on-site inspection programs for both domestic and overseas manufacturers. This has created additional challenges for our existing reliance mechanisms requiring similar flexibility in our regulatory oversight.

In order to support industry, we have implemented a temporary change to our documentation requirements for GMP Clearance applications submitted through the Compliance Verification (CV) pathway during the COVID-19 pandemic. 

In order to support your GMP Clearance application, Sponsors may provide:

  • A recently expired inspection report from a recognised regulator, and
  • a GMP Clearance questionnaire as well as any additional documents identified during the completion of the questionnaire

GMP Clearance applications will be assessed using our risk-based approach and as per our existing process, outcomes will be dependent on the quality of the application and information provided. Assessments that identify certain risk criteria may still require a remote GMP inspection.

There are no changes to GMP Clearance where current evidence is available. There is also no change to the existing MRA pathway and sponsors are encouraged to continue to submit their renewal applications using the existing evidence available.

Fees

The fees (including inspection hourly rates) outlined in the fees and charges summary will continue to be charged for the above inspection and GMP Clearance processes in line with our cost recovery requirements.

Contact us

The TGA is committed to working with Australian sponsors during this time. Our staff are available to assist via the contact information below:

  • For domestic and overseas inspections and general GMP enquiries, contact the Licensing and Certification Section: GMP@health.gov.au
  • For overseas GMP Clearance desk-top assessments and extensions to GMP Clearances, contact the GMP Clearance section: GMPClearance@health.gov.au

Additional information about the TGA's response to coronavirus (COVID-19) is available on our website.