Drug Evaluation Committee 2009-07 Clinical Trial Review Committee Established by a Medical Corporation
Related classification: Clinical Trial Review Committee
First published: Jul 2009
Revised publication date: Mar. 2021
Question
In question No. 2008-09, it is stated that "clinical trial review committees established by medical corporations are not recognized", but are clinical trial review committees established by medical associations recognized (although I am not sure of the difference between the two)?
I ask this question because there is in fact an IRB established by a medical corporation association.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Under the Medical Care Act, Article 39, paragraph 1 "An association or foundation that intends to establish a hospital, a clinic where a physician or dentist is in regular practice, a geriatric healthcare facility, or a long-term care medical care hospital may become a corporation pursuant to the provisions of this Act." and Paragraph 2, "A corporation under the provisions of the preceding paragraph shall be called a medical corporation." The provisions of the previous paragraph are as follows. Therefore, the medical corporation association in question is considered to be a medical corporation as defined in the Medical Care Act. Since GCP does not permit a clinical trial review committee established by a medical corporation, we assume that the same applies to a medical incorporated association.
Reason for revision of opinion
The description has been updated in accordance with the revision of the Medical Care Act.