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JAPAN Notification 0401022 ERES Guideline

  • 1.  JAPAN Notification 0401022 ERES Guideline

    Posted 28-Aug-2023 10:55
    Hello Everyone,

     In review of the notification, "Points to Consider for Informed Consent Using Electromagnetic Means in Clinical Trials and Post-marketing Clinical Trials", the following were referenced:

    • Ministerial Ordinance on Good Clinical Practice for Regenerative Medical Products (MHLW Ordinance No. 89 in 2014) (referred to as "GCP Ordinance" in the Annex)

    • Annex to the "Use of Electromagnetic Records and Electronic Signatures in Submission for Application for Marketing Approval or Licensing of drugs, etc." (PFSB Notification No. 0401022 dated April 1, 2005 issued by the Director of Pharmaceutical and Food Safety Bureau, MHLW) (hereinafter referred to as the "ER/ES Guideline"

    • "Partial revision of 'Basic Concept of the Use of Electromagnetic Records in Clinical Trial-related Documents'" (Administrative Notice of the Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, MHLW dated July 1, 2014) (hereinafter referred to as "Basic Concept of the Use of Electromagnetic Record")


    Does anyone have a website I could go to for the above documents or have a copy of them?  I have searched the PMDA website and was unable to find them.

    Thanks
    Kimberly "Kim" Gallop
    Global Regulatory Specialist at Florence

    E kimberly.gallop@florencehc.com ­W www.florencehc.com/ ­


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