Drug Evaluation Committee 2016-16 Change in the Form of Establishment of a Clinical Trial Review Committee Establisher
Related classification: Clinical Trial Review Committee
Date of first publication: August 2016
Question
One organization that currently has a Clinical Trial Review Committee as a non-profit organization is considering becoming a public interest incorporated association in the future after becoming a general incorporated association. However, the "establisher of a clinical trial review committee" stipulated in Article 27 of the GCP does not include a public interest incorporated association, so we would like to know the following.
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(1)If the organization becomes a public interest incorporated association, can it continue to establish a Clinical Trial Review Committee?
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(2)If so, are there any requirements for such an organization? (For example, it must meet the requirements of GCP Article 27, Paragraph 2, etc.)
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
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(1)As stated in the Act on Authorization of Public Interest Incorporated Associations and Public Interest Incorporated Foundation (Act No. 49 of June 2, 2006), a public interest incorporated association is a public interest incorporated association. Therefore, a public interest incorporated association is a type of general incorporated association and can establish a Clinical Trial Review Committee.
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(2)As a general incorporated association, it is required to satisfy the provisions of Article 27, Paragraph 2 of the GCP.