AAMRI Feedback on the TGA’s proposed Good Clinical Practice (GCP) Inspections Program

AAMRI Feedback on the TGA’s proposed Good Clinical Practice (GCP) Inspections Program

1st March, 2019

The Therapeutic Goods Administration (TGA) recently sought comments from interested parties on a pilot Good Clinical Practice (GCP) Inspections Program of 12 months duration that will inform a routine GCP Inspections Program. The consultation aims to outline the rationale for introducing a domestic GCP Inspections Program for clinical trials conducted in Australia under the Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) schemes. The consultation will also provide preliminary information on a risk-based approach to selection of inspections sites, and the management of findings of non-compliance.

AAMRI is supportive of the pilot and proposed routine inspection programs as outlined in the consultation paper. In the submission, AAMRI recommends that in developing and implementing the inspection programs consideration should be given to the following areas:

  • the resources required by organisations conducting clinical trials to participate in inspections
  • potentially decreasing the attractiveness of the CTN scheme if the progress of trials were slowed by an inspections program
  • how clinical trials are selected for the pilot inspections program
  • ensuring that the cost of the routine inspection program is fully funded from the TGA budget