Drug Evaluation Committee 2017-38 Indication of the Diversion of Marketed Products in Expanded Clinical Trials
Related classification: Investigational drugs
Date first published: December 2017
Question
This is a question regarding the diversion of marketed products to clinical trials in expanded clinical trials.
The PMDA's response to public comments (dated June 10, 2016, regarding comments received in response to a request for opinions on the "Draft Ministerial Ordinance Partially Amending the Ministerial Ordinance Concerning Standards for Conducting Clinical Trials on Pharmaceuticals (tentative name)" (draft framework)) states, "For pharmaceutical products that are diverted for use in a clinical trial, Is it correct to understand that the investigational new drug manager should indicate "investigational use" when the drug is diverted for investigational use? In response to the question, "In the case of a drug that is converted for use in a clinical trial, the sponsor or the person who conducts the clinical trial must provide the necessary labeling for conversion. This means that the investigational new drug administrator is responsible for the labeling. Should this be read to mean that the investigational drug administrator cannot perform work related to labeling? Or can it be read to mean that if the sponsor establishes an appropriate procedure, the investigational drug administrator can perform the work (in other words, in order for the investigational drug administrator to perform the work, the procedure must be appropriately established)?
Also, if the investigational product manager cannot perform the work related to labeling, would it be appropriate for a monitor to perform the work? If so, is there any difference between in-house and outsourced work?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 17, Paragraph 1 of the GCP stipulates that when an extended clinical trial is conducted, the investigational drug in the inventory of the site may be used for the clinical trial. The sponsor must indicate the necessary information on the container or package of the investigational new drug at a place where appropriate manufacturing and quality control methods are adopted.
On the other hand, in "Concerning the Implementation of Clinical Trials Conducted from a Humanitarian Standpoint (Pharmaceutical Affairs Agency Announcement No. 0122, January 22, 2008)," it is stated that "From the perspective of increasing the possibility of conducting expanded clinical trials, the GCP Ministerial Ordinance was also revised to reduce the burden on the person conducting the clinical trial," and we believe that the purpose of the revision can also be considered. In light of the above, we believe that the purpose of the amendment can be taken into account.
Based on the above, we believe that the person who can perform work related to the labeling of investigational new drugs is not necessarily limited to the sponsor, and that it is essential that proper labeling is performed in an appropriate place and method and in compliance with GMP for investigational new drugs.
The requirements may vary depending on individual circumstances and the characteristics of the investigational product. We recommend that the relevant parties within the sponsor review the requirements and, if necessary, confirm with the regulatory authorities.