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  • 1.  PMDA References in MDSAP Companion Document

    Posted 12-Apr-2018 11:29
    I am reading through the country specific requirements listed in MDSAP G0002.1004 Companion Document. In the section for Japan (MHLW) there are multiple references to "PMD Act 23-xxx" (i.e. PMD Act 23-2.1, PMD Act 23-2-23.1, PMD Act 23-2-5.1, PMD Act 23-2-5.6, 7). I know that the PMDA is the Japanese version of the FDA (apologies for the ethnocentric description). I am familiar with the MHLW MO169 document referenced many times in the Companion Document.

    I consider myself a skilled Google-er but I cannot for the life of me find any PMDA document which has these numerical references. I have been pointed over and over to the 2017 version of "Pharmaceutical Administration and Regulations in Japan", but if this is the correct document, I have no idea where to find these references within.

    Does anyone know where these numerical references are located?

    Thank you in advance!

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    Lillian Erickson
    QA/RA Director
    Salt Lake City UT
    United States
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  • 2.  RE: PMDA References in MDSAP Companion Document

    Posted 12-Apr-2018 12:05
    Lillian:

    In Japan, PAL has been revised to restructure the regulatory framework.  The PAL has been renamed, dated Nov 25, 2014, as the Pharmaceutical and Medical Device Act (so called, PMD Act).  The PMD Act consists of 17 chapters and 91 articles.  

    The PMD Act 23-xxx refers to article(s) of the PMD Act. 

    David


    ------------------------------
    Dr. David Lim, Ph.D., RAC, ASQ-CQA
    REGULATORY DOCTOR
    http://www.RegulatoryDoctor.US
    http://www.GlobalComplianceSeminar.com
    Phone (Toll-Free): 1-(800) 321-8567
    E-mail: David@RegulatoryDoctor.US
    ------------------------------

    Original Message


  • 3.  RE: PMDA References in MDSAP Companion Document

    Posted 13-Apr-2018 08:00
    ​Go to:  http://www.japaneselawtranslation.go.jp/?re=02
    Select "Law Search"
    Enter PMDA in search field

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    Gary Minks
    Head of QA/RA
    Siemens Healthineers / Dedicated2Imaging
    Portsmouth, NH
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    Original Message


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