Is it Possible for the Investigators in Academia to Purchase Manufacturing-specific Drugs for Manufacturing Investigational Drug Themselves in Japan?　―Interpretation of the Notice of the Director-general Regarding Article 138 of the Act on Securing Quality, Efficacy, and Safety of Products Including Pharmaceuticals and Medical Devices―

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  • KAMIYAMA Naoya
    Clinical Research Support Center, Asahikawa Medical University Hospital, Japan
  • TAKEHARA Naofumi
    Clinical Research Support Center, Asahikawa Medical University Hospital, Japan
  • MANABE Takayuki
    Clinical Research Support Center, Asahikawa Medical University Hospital, Japan
  • TASAKI Yoshikazu
    Clinical Research Support Center, Asahikawa Medical University Hospital, Japan
  • MATSUMOTO Seiji
    Clinical Research Support Center, Asahikawa Medical University Hospital, Japan

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  • アカデミアが主体となって行う治験薬製造における製造専用医薬品の購入 ―薬機法施行規則第138 条に関する局長通知の解釈について―

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<p>The authors attempted to manufacture an investigational drug using a manufacturing facility within the university without outsourcing it to a contract manufacturing organization (CMO). However, they experienced difficulty in purchasing an exclusive drug as a raw material for the process. The authors made inquiries to the Ministry of Health, Labor and Welfare (MHLW) about the interpretation of the Notice of the Director-General regarding Article 138 of the Act on Securing Quality, Efficacy, and Safety of Products Including Pharmaceuticals and Medical Devices. The response was that the purchase of drugs dedicated to manufacture of investigational products for the purpose of administering them to humans may be possible, even if the manufacturing facilities are in a university that does not have the license for pharmaceutical manufacturing of drugs. Raw materials derived from manufacturing-specific drugs or (non-manufacturing) medical drugs, which are considered to be safer in humans than as research reagents, should consistently meets safety requirements for study subjects. Therefore, the regulatory authorities should consider revising the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices or the Notification by the Director-General to allow the purchase of drugs by research institutions for the purpose of manufacturing investigational drugs or test drugs to be used in clinical studies, and that investigational drugs or products be used for clinical research at research institutions, or that “the purpose of research should include clinical trials and clinical research.”</p>

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