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

The TGA, Australia has provided an update on its GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic. The update concerns certain temporary measures introduced in 2020 for overseas manufacturers.

The following items are addressed:

On-going use of Remote Inspections

At the time of introduction of its remote GMP inspection program. in mid-2020, TGA contacted sponsors with submitted applications for an inspection prior to including them in the program. This will no longer occur as remote inspections have become the only available option for certification applications during the pandemic while international travel restrictions remain in place.

Prioritisation of remote GMP inspections of overseas manufacturers will be based upon:

  • the ability to use the alternative GMP Clearance processes
  • current compliance information
  • applications for marketing authorisation
GMP Clearance

TGA is liaising with its international regulatory partners to understand the range of approaches being taken regarding GMP inspections. This information is assessed and its effect on TGA’s GMP Clearance framework considered.

Compliance Verification (CV) pathway

For the CV pathway:

  • TGA will accept an inspection report issued following a successful remote inspection or distant assessment in addition to or, in certain circumstances, in lieu of the GMP Clearance questionnaire.
  • In such circumstances, Sponsors should be able to justify why the report removes the need for the GMP Clearance questionnaire.
  • Sponsors should contact sends e-mail) prior to submitting applications if there are doubts around the suitability of any evidence.
  • TGA does not accept inspection reports issued following a remote inspection or distant assessment as the primary evidence for a GMP Clearance i.e. it does not replace an inspection report from a physical on-site inspection.
  • Additionally, where applicants have already used the GMP Clearance questionnaire option, a TGA remote inspection will most likely be required for any subsequent application.
Mutual Recognition Agreement (MRA) pathway

For the MRA pathway:

An additional period of validity, beyond that recommended by TGA’s MRA partners, will be applied to a GMP Clearance where possible and will be determined by:

  • the type of manufacturing steps being performed at the facility
  • the length of time since the last physical inspection by the national authority
  • the level of oversight applied by the national authority such as remote inspections and distant assessments

Source: TGA website