Drug Evaluation Committee 2012-15 Use of Unapproved Drugs as Target Drugs in Japan
Related classification: Other
First published: August 2012
Question
In the clinical trial for which we are considering contracting, the control drug is unapproved in Japan. Although the drug is approved in our country, we are told that the drug approved in Europe will be used in the batch because it is an international joint clinical trial.
Question 1
Can the approval of the investigational drug be granted in Japan based on the results of the clinical trial conducted with the control drug, which is not approved in Japan?
Question 2
As a medical institution, do we have any obligation to obtain safety information on the control drug and communicate it to the subjects?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Question 1
It is possible to conduct a study using a drug that is not approved in Japan as a control drug and apply for approval. The Ministry of Health, Labour and Welfare (MHLW) has decided that it is necessary to promote international clinical trials in order to eliminate the drug lag and to clarify the basic concept of conducting international clinical trials from the viewpoint of approval review, and therefore, on September 28, 2007, the Ministry of Health, Labour and Welfare issued a notice No. 0928010, "Basic Principles on International Joint Clinical Trials" by the Director, Evaluation and Management Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare (hereinafter referred to as the "Notice"). The notice, "Basic Policy on International Clinical Trials," was promulgated on September 28, 2007. The notice states, "If it can be objectively explained from the descriptions in the guidelines of other countries that the actual drug is an internationally standard drug, it is possible to conduct the study as a control drug in a clinical trial, even if the drug is unapproved in Japan.
Question 2
Article 51, Paragraph 1, Item 5 of the GCP states that the following items should be described in the explanatory document for subjects: "the anticipated benefits of the investigational drug on the subject's mental and physical health (if no such benefits are anticipated, a statement to that effect) and the anticipated disadvantages to the subject". Since "investigational drug" includes the control drug, the site (investigator, etc.) must receive safety information on the control drug from the sponsor, and must comply with the requirements of Article 51, Paragraph 1 (provision of consent and explanation documents as information prior to the start of a clinical trial) and Article 54, Paragraph 1 (provision of information when information is obtained that may influence the subject's decision) of the GCP. The safety information on the controlled drug must be communicated to the subject in accordance with Article 51, Paragraph 1 of GCP (delivery of consent and explanation documents as information provision prior to the start of the clinical trial) and Article 54, Paragraph 1 (provision of information when information is obtained that may influence the subject's decision).