Presentation Regulatory framework for PET imaging clinical trials in Japan

栗原, 千絵子

Purpose: To identify actual status and future perspective of regulatory framework for PET imaging clinical trials in japan to facilitate sound scientific, efficient clinical development of therapeutic and diagnostic drugs. Method: Narrative, non-systematic review Findings: Japan is now at the critical turning point from traditional status toward regulatory reformation both in views of (1) general regulatory framework for clinical trials; as well as (2) regulations concerning PET imaging. Traditional regulatory framework:(1)Generally, Pharmaceutical Affairs Laws and Good Clinical Practice (GCP) Ordinance covers clinical trials aiming at new drug applications (NDA); meanwhile, investigator-initiated clinical trials (IITs) without intention of NDA are covered governmental ethical guidelines for clinical research, which does not involve quality assurance system of the data generated from the research.(2)Because of Japanese regulatory policy, hospitals and research institutes cannot get regulatory approval of in-house manufactured PET drugs, therefore, difficulties remain for facilitate regulatory approval of new PET drugs following FDG.Regulatory reformations:(1)The revised governmental guideline for research involving human subjects was just issued at the end of 2014, and at the same time governmental policy report to develop laws for clinical research was finalized. Both are intended to strengthen credibility of IITs and to facilitate utilization of results of IITs for regulatory approval of new medical technologies. (2)Japanese government has been facilitating a policy to grant medical device approvals to manufacturers of synthesizer apparatus of new PET drugs, instead of granting drug approval to hospitals or research institutes for their in-house manufacturing. The Japanese Society of Nuclear Medicine (JSNM) provide quality assurance scheme for the institutes who introduce newly approved synthesizers, by means of auditing in-house PET drug manufacturing as well as scanner validation.Conclusions: To facilitate sound scientific, efficient clinical development of therapeutic and diagnostic drugs in Japan, it is prerequisite to accomplish the above regulatory reformation, involving JSNM-initiated quality assurance scheme.
日中核医学交流合同シンポジウム参加及び研究打ち合わせ主催機関及び責任者:外山 宏 (日本核医学会日中核医学交流会委員長)事務局:藤田保健衛生大学医学部放射線医学教室〒470-1192 愛知県豊明市沓掛町田楽ケ窪1-98TEL:0562-93-9259 / FAX:0562-95-2253E-mail:

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