Drug Evaluation Committee 2008-25 Rescission of previously approved items by a Clinical Trial Review Committee
Related classification: Clinical Trial Review Committee
First published: Jan. 2009
Revised publication date: Mar. 2021
Question
The following items are listed in GCP Article 28, Paragraph 2, Operational Notification 2 (3) <3>Matters related to the opinion of the Clinical Trial Review Committee regarding the clinical trial.
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(a) Approval (b) Approval (c) Approval (d) Approval (e)Approval
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BApprove with modifications
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CReject
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Reject with modificationRevocation of an already approved item (including discontinuation or suspension of a clinical trial)
If the option "d. Cancellation of matters already approved (including suspension or discontinuation of the clinical trial)" is selected, please tell us in which case it should be used.
The hospital director submits a "Request for Review of Clinical Trial" to the Trial Review Committee, the Trial Review Committee deliberates on the matters submitted, and submits a "Notification of Results of Clinical Trial Review" to the hospital director. If you choose option "d", I imagine that it will be used when the hospital director requests the investigational review committee to deliberate on the approved items again. If there are any cases where the "d" option is used, please let us know.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
A clinical trial review committee that is asked for its opinion on the appropriateness of continuation of a clinical trial by the head of the implementing medical institution pursuant to Article 31, Paragraph 1 or Paragraph 2 of the GCP, examines the continuation of the clinical trial and notifies its opinion in writing to the head of the implementing medical institution. The following is indicated in Article 32, Paragraph 3, Guidance 2 of the GCP.
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1) Number of reports and countries from which data was obtainedApproval
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2)Approve with modifications
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3)Revocation of an already approved item (including suspension or discontinuation of a clinical trial)
The opinion (3) corresponds to "d. Revocation of matters already approved (including suspension or discontinuation of the clinical trial)".
Although we are not able to answer specific cases that fall under this opinion 3), the Clinical Trial Review Committee may issue a notice of opinion (including a recommendation to suspend or discontinue the clinical trial) to "revoke the already approved items" as a result of review from ethical, scientific, medical and pharmacological perspectives, based on new information obtained during the clinical trial and the status of implementation of the clinical trial. The committee may also issue an opinion (including a recommendation to suspend or discontinue the clinical trial) as a result of the review from the ethical, scientific, medical and pharmacological viewpoints.
Reason for revision of opinion
The description has been improved in accordance with the revision of the GCP guidance issued on August 31, 2020 (Pharmaceutical Affairs Council of Japan, No. 0831-15).