Drug Evaluation Committee 2011-11 Combination of In-Hospital Preparations and Investigational New Drugs
Related classification: Other
First published: Aug 2011
Question
Since the in-hospital preparation can be interpreted as an independent clinical trial, is it correct to assume that the combination is not allowed in this case, just as the combination of an investigational drug and another investigational drug is not allowed? Also, is there a difference in interpretation depending on the composition and formulation of the in-hospital preparation? Specifically, we are talking about the case of an investigational drug and an in-house formulation of thecaine ointment, and an investigational drug and an in-house formulation of capsaicin ointment.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
There are a variety of in-hospital preparations, some of which have not been adequately confirmed to be effective and safe. Therefore, we cannot deny the possibility that concomitant use of these products with investigational drugs may be dangerous for the safety of subjects. If a physician determines that it is in the patient's best interest to allow a patient who is using an in-hospital preparation to participate in a clinical trial, he or she should confirm with the sponsor individually whether the in-hospital preparation can be used and whether the patient can participate in the clinical trial, and if necessary, the clinical trial should be started after receiving review by the investigational review committee.