Drug Evaluation Committee 2012-33 Drafting Dates for Timing of Continuing Review (Part 2)
Related classification: Clinical Trial Review Committee
Date of first publication: December 2012
Question
At the initial review by the Clinical Trial Review Committee, a conditional approval was issued to modify some of the materials to be reviewed. In this case, which date should be used as the starting date for the continuing review, the "date of conditional approval at the initial review" or the "date of approval for the revised materials"?
There is a clinical trial in which approval was obtained after six months had elapsed since the conditional approval was obtained at the initial review, after amending the materials subject to the review. Since the trial should start after the approval is obtained after the material is revised, I am thinking that it should be on the "date of approval with revised material", but what do you think?
Also, should the start date of the clinical trial period also be the "date of approval in the revised documents"?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Please refer to the previous Opinion 2008-12 for the concept of the starting date of the continuing review.
The purpose of the continuing review stipulated in Article 31 of the GCP is to review the appropriateness of continuing the clinical trial and whether or not the clinical trial is being conducted appropriately. Therefore, we think it is appropriate to use the date when the clinical trial actually started, i.e., the date when the contract was concluded, as the starting date, rather than the date of approval by the Clinical Trial Review Committee.