01/11/2019 | News release | Distributed by Public on 01/10/2019 22:40
This consultation closes on 22 February 2019.
Invitation to comment
The TGA is seeking 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.
Document released for consultation on Friday, 11 January 2019.
Interested parties should respond by close of business Friday, 22 February 2019.
Feedback will be released following consideration of submissions. (See 'What will happen').
About the consultation
The purpose of this consultation is 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. Clinical Investigators, clinical trial sponsors, and other stakeholders are invited to provide feedback on a pilot program. In addition, volunteers are sought to participate in a pilot Good Clinical Practice (GCP) Inspections Program.
Australia's CTN scheme provides advantages in speed, cost and access however, unlike comparable medicines regulatory schemes in other countries, primary responsibility for assessing the trial design, safety and efficacy of the medicine or device, and approval of the trial protocol, lies with the approving Human Research Ethics Committee (HREC). This impacts on the TGA's ability to identify risk over the life of the clinical trial, and is compounded by the absence of a routine GCP inspections program to determine whether the conduct of the trial complies with international GCP guidelines and the Therapeutic Goods Regulations 1990.
The Australian Government is working collaboratively with jurisdictions to progress a number of clinical trials related initiatives. In addition, the Government has established a Clinical Trials Collaborative Forum as an important engagement mechanism for shared problem solving. The development of a National Clinical Trials Front Door concept will integrate key clinical trial approval and reporting processes. Australia's position in a globally competitive clinical trial environment is based on international recognition of clinical trial data quality and integrity, which would be improved by a regulatory GCP inspections program. These initiatives build and protect our competitive advantages in this sector.
Content of submissions
Submissions may address any, or all, questions or matters relating to the pilot GCP inspections program or other identified issues.
In addition, submissions might include:
How to submit
Complete the online consultation submission form to upload your submission in either pdf or word format.
Alternatively, hardcopy submissions with a printed cover sheet may be mailed to:
Manufacturing Quality Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Any questions relating to submissions should be directed to the GCP Inspections Project Team by email to [email protected] or by telephone to 1800 020 652.
What will happen
All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).
Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.
This information will be used in combination with the learnings from the pilot program to inform the development and implementation of an ongoing routine GCP Inspections Program.