Drug Evaluation Committee 2014-26 Necessity of Retention of Recovered Investigational Medicines in Double-blind Studies
Related classification: Other
Date of first publication: November 2014
Question
Should the investigational drug returned by Investigator Site in a double-blind study be kept as long as possible in preparation for the reliability survey after the application for approval? Or is it appropriate to keep the record and dispose of it?
JPMA's Opinion
The sponsor is required by GCP Article 16, Paragraph 5 and Article 26 to prepare and maintain records of the manufacture, delivery, collection, and disposal of investigational new drugs at each Investigator Site, but the retention period of investigational new drugs collected from Investigator Sites is not specified.
On the other hand, in a blinded clinical trial, the investigational drug must be coded, labeled and packaged in a manner that maintains blindness (GCP Article 16, Paragraph 3, Guidance 1). In the conformity investigation, the sponsor must explain that the blindness of the clinical trial was maintained based on the above records and lot samples, etc. Whether or not the investigational drug is retained until it is recovered from the Investigator Site for this explanation is up to the sponsor's policy.
Please refer to the website of the Pharmaceuticals and Medical Devices Agency (PMDA) for the items to be investigated in the conformity survey regarding manufacturing and management of investigational new drugs.