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Consultation: Good Clinical Practice Inspections Program

11 January 2019

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.

Consultation documents

How to access a pdf or Word document

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Timetable

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.

Background

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:

  • comments on a proposal to release inspection findings to the approving HREC and/or Authorising Institution;
  • an assessment of how the proposed GCP Inspections Program will impact on you; and/or
  • what you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

How to submit

Complete the online consultation submission form to upload your submission in either pdf or word format.

Consultation submission form

Alternatively, hardcopy submissions with a printed cover sheet may be mailed to:

Inspections Section
Manufacturing Quality Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

How to access a Word document

Enquiries

Any questions relating to submissions should be directed to the GCP Inspections Project Team by email to info@tga.gov.au 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.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
    • seek feedback about how the consultation was undertaken.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
  • More information on consultations and privacy is included in the submission form and on our website.