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 investigational new drugs returned by a medical institution in a double-blind study be retained as long as possible in preparation for reliability surveys, etc. after submission for approval? Or is it appropriate to dispose of them with their records?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The sponsor is required by GCP Article 16, Paragraph 5 and Article 26 to prepare and retain records related to the manufacture, delivery, collection, and disposal of investigational drugs for each site, but the retention period of investigational drugs collected from 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 assessment, 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 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.