<leaf 
  operation="new" 
  ID="ID00019496" 
  application-version="PDF 1.6" 
  checksum-type="MD5" 
  checksum="db355f9f35f23ac04e9fd00b62c1849a" 
  xlink:href="m3/33-lit-ref/literature-references-toc-2.pdf">
  <title>happy new year</title>
</leaf>

<leaf 
  operation="replace"
  ID="ID00019586" 
  application-version="PDF 1.4" 
  checksum-type="MD5" 
  checksum="120e1347ce7021350199c43b245c8813" 
  modified-file="../0000/index.xml#ID00019496" 
  xlink:href="m3/33-lit-ref/literature-references-toc.pdf">
  <title>we wish you a merry christmas</title>
</leaf>

<leaf 
  operation="delete"
  ID="ID00019435" 
  checksum-type="" 
  checksum="" 
  modified-file="../0000/index.xml#ID00019435">
  <title>hello, ectd</title>
</leaf>
  

<?xml version="1.0" encoding="UTF-8" standalone="no" ?>
<!DOCTYPE tw:tw-backbone SYSTEM "../../util/dtd/tw-regional.dtd">
<?xml-stylesheet type="text/xsl" href="../../util/style/tw-regional.xsl"?>
<tw:tw-backbone xmlns:tw="http://www.fda.gov.tw" dtd-version="2.0" xmlns:xlink="http://www.w3c.org/1999/xlink">
  
  <tw-envelope>
    <envelope>
      <identifier>請填入UUID(一個dossier一組UUID，所有序列共用同一組)</identifier>
      <submission objective="new">
        <type tier1="domestic" tier2="new-drugs-application" tier3="prescription" tier4="new-chemical-entity" tier5=""/>
      </submission>
      <submission-unit type="initial"/>
      <applicant>
        <name>台灣藥品股份有限公司</name>
        <corporate-certification-authority>工商憑證IC卡號(MG...)</corporate-certification-authority>
        <phone-number>+886-4-1234-5678</phone-number>
        <email-address>happy@are.you.ok</email-address>
      </applicant>
      <procedure type="national"/>
      <invented-name>
        <name>藥品名稱</name>
        <drug-permit-license>衛部藥製字第000000號</drug-permit-license>
        <pre-assigned-application-number>取號號碼</pre-assigned-application-number>
        <code>取號號碼+高低劑量</code>
      </invented-name>
      <inn>主成分名稱</inn>
      <sequence>0000(序列號碼)</sequence>
      <related-sequence>0000(相關序列)</related-sequence>
      <submission-description>新藥查驗登記初始送件(序列描述)</submission-description>
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        <m1-3-1-3-orilab><leaf>...</leaf></m1-3-1-3-orilab> <!-- 13-labart/131-lab/1313-orilab/orilab-001.pdf -->
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      <leaf>...</leaf> <!-- 14-lic/lic-001.pdf -->
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      <m1-4-2-busilic><leaf>...</leaf></m1-4-2-busilic> <!-- 14-lic/142-busilic/busilic-001.pdf -->
      <m1-4-3-prodlic><leaf>...</leaf></m1-4-3-prodlic> <!-- 14-lic/143-prodlic/prodlic-001.pdf -->
      <m1-4-4-locmanuflic><leaf>...</leaf></m1-4-4-locmanuflic> <!-- 14-lic/144-locmanuflic/locmanuflic-001.pdf -->
      <m1-4-5-gdpappro><leaf>...</leaf></m1-4-5-gdpappro> <!-- 14-lic/145-gdpappro/gdpappro-001.pdf -->
    </m1-4-lic>
    <m1-5-letauthor><leaf>...</leaf></m1-5-letauthor> <!-- 15-letauthor/letauthor-001.pdf -->
    <m1-6-refcountryappro>
      <leaf>...</leaf> <!-- 16-refcountryappro/refcountryappro-001.pdf -->
      <m1-6-1-pharmaprodcerti><leaf>...</leaf></m1-6-1-pharmaprodcerti> <!-- 16-refcountryappro/161-pharmaprodcerti/pharmaprodcerti-001.pdf -->
      <m1-6-2-salecerti><leaf>...</leaf></m1-6-2-salecerti> <!-- 16-refcountryappro/162-salecerti/salecerti-001.pdf -->
    </m1-6-refcountryappro>
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    <m1-8-gmpcerti><leaf>...</leaf></m1-8-gmpcerti> <!-- 18-gmpcerti/gmpcerti-001.pdf -->
    <m1-9-bridgevalu><leaf>...</leaf></m1-9-bridgevalu> <!-- 19-bridgevalu/bridgevalu-001.pdf -->
    <m1-10-locclinicalstudy><leaf>...</leaf></m1-10-locclinicalstudy> <!-- 110-locclinicalstudy/locclinicalstudy-001.pdf -->
    <m1-11-locbabestudy><leaf>...</leaf></m1-11-locbabestudy> <!-- 111-locbabestudy/locbabestudy-001.pdf -->
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      <m1-12-3-contractmanufprodecrip><leaf>...</leaf></m1-12-3-contractmanufprodecrip> <!-- 112-contractmanuf/1123-contractmanufprodecrip/contractmanufprodecrip-001.pdf -->
    </m1-12-contractmanuf>
    <m1-13-riskmanagplan><leaf>...</leaf></m1-13-riskmanagplan> <!-- 113-riskmanagplan/riskmanagplan-001.pdf -->
    <m1-14-dmfletter><leaf>...</leaf></m1-14-dmfletter> <!-- 114-dmfletter/dmfletter-001.pdf -->
    <m1-15-desigapproletter><leaf>...</leaf></m1-15-desigapproletter> <!-- 115-desigapproletter/desigapproletter-001.pdf -->
    <m1-16-refagenassessreport><leaf>...</leaf></m1-16-refagenassessreport> <!-- 116-refagenassessreport/refagenassessreport-001.pdf -->
    <m1-17-others><leaf>...</leaf></m1-17-others> <!-- 117-others/others-001.pdf -->
  </m1-tw>
  
</tw:tw-backbone>
  

<?xml version="1.0" encoding="UTF-8" standalone="no" ?>
<!DOCTYPE ectd:ectd SYSTEM "util/dtd/ich-ectd-3-2.dtd">
<?xml-stylesheet type="text/xsl" href="util/style/ectd-2-0.xsl"?>
<ectd:ectd xmlns:ectd="http://www.ich.org/ectd" dtd-version="3.2" xmlns:xlink="http://www.w3c.org/1999/xlink">

  <m1-administrative-information-and-prescribing-information>
    <leaf ID="ID00019004" checksum="f09e7f205ac26c82ea95e5e38ed3bddf" checksum-type="MD5" operation="new" xlink:href="m1/tw/tw-regional.xml">
      <title>tw-regional.xml</title>
    </leaf>
  </m1-administrative-information-and-prescribing-information>
  
  <m2-common-technical-document-summaries>
    <leaf>...</leaf>
    <m2-2-introduction><leaf>...</leaf></m2-2-introduction>
    <m2-3-quality-overall-summary>
      <leaf>...</leaf>
      <m2-3-introduction><leaf>...</leaf></m2-3-introduction>
      <m2-3-s-drug-substance substance="Example Substance" manufacturer="Example Manufacturer"><leaf>...</leaf></m2-3-s-drug-substance>
      <m2-3-p-drug-product product-name="Example Product" dosageform="Tablet" manufacturer="Example Manufacturer"><leaf>...</leaf></m2-3-p-drug-product>
      <m2-3-a-appendices><leaf>...</leaf></m2-3-a-appendices>
      <m2-3-r-regional-information><leaf>...</leaf></m2-3-r-regional-information>
    </m2-3-quality-overall-summary>
    <m2-4-nonclinical-overview><leaf>...</leaf></m2-4-nonclinical-overview>
    <m2-5-clinical-overview><leaf>...</leaf></m2-5-clinical-overview>
    <m2-6-nonclinical-written-and-tabulated-summaries>
      <leaf>...</leaf>
      <m2-6-1-introduction><leaf>...</leaf></m2-6-1-introduction>
      <m2-6-2-pharmacology-written-summary><leaf>...</leaf></m2-6-2-pharmacology-written-summary>
      <m2-6-3-pharmacology-tabulated-summary><leaf>...</leaf></m2-6-3-pharmacology-tabulated-summary>
      <m2-6-4-pharmacokinetics-written-summary><leaf>...</leaf></m2-6-4-pharmacokinetics-written-summary>
      <m2-6-5-pharmacokinetics-tabulated-summary><leaf>...</leaf></m2-6-5-pharmacokinetics-tabulated-summary>
      <m2-6-6-toxicology-written-summary><leaf>...</leaf></m2-6-6-toxicology-written-summary>
      <m2-6-7-toxicology-tabulated-summary><leaf>...</leaf></m2-6-7-toxicology-tabulated-summary>
    </m2-6-nonclinical-written-and-tabulated-summaries>
    <m2-7-clinical-summary>
      <leaf>...</leaf>
      <m2-7-1-summary-of-biopharmaceutic-studies-and-associated-analytical-methods><leaf>...</leaf></m2-7-1-summary-of-biopharmaceutic-studies-and-associated-analytical-methods>
      <m2-7-2-summary-of-clinical-pharmacology-studies><leaf>...</leaf></m2-7-2-summary-of-clinical-pharmacology-studies>
      <m2-7-3-summary-of-clinical-efficacy indication="Example Indication"><leaf>...</leaf></m2-7-3-summary-of-clinical-efficacy>
      <m2-7-4-summary-of-clinical-safety><leaf>...</leaf></m2-7-4-summary-of-clinical-safety>
      <m2-7-5-literature-references><leaf>...</leaf></m2-7-5-literature-references>
      <m2-7-6-synopses-of-individual-studies><leaf>...</leaf></m2-7-6-synopses-of-individual-studies>
    </m2-7-clinical-summary>
  </m2-common-technical-document-summaries>
  
  <m3-quality>
    <leaf>...</leaf>
    <m3-2-body-of-data>
      <leaf>...</leaf>
      <m3-2-s-drug-substance substance="Example Substance" manufacturer="Example Manufacturer">
        <leaf>...</leaf>
        <m3-2-s-1-general-information>
          <leaf>...</leaf>
          <m3-2-s-1-1-nomenclature><leaf>...</leaf></m3-2-s-1-1-nomenclature>
          <m3-2-s-1-2-structure><leaf>...</leaf></m3-2-s-1-2-structure>
          <m3-2-s-1-3-general-properties><leaf>...</leaf></m3-2-s-1-3-general-properties>
        </m3-2-s-1-general-information>
        <m3-2-s-2-manufacture>
          <leaf>...</leaf>
          <m3-2-s-2-1-manufacturer><leaf>...</leaf></m3-2-s-2-1-manufacturer>
          <m3-2-s-2-2-description-of-manufacturing-process-and-process-controls><leaf>...</leaf></m3-2-s-2-2-description-of-manufacturing-process-and-process-controls>
          <m3-2-s-2-3-control-of-materials><leaf>...</leaf></m3-2-s-2-3-control-of-materials>
          <m3-2-s-2-4-controls-of-critical-steps-and-intermediates><leaf>...</leaf></m3-2-s-2-4-controls-of-critical-steps-and-intermediates>
          <m3-2-s-2-5-process-validation-and-or-evaluation><leaf>...</leaf></m3-2-s-2-5-process-validation-and-or-evaluation>
          <m3-2-s-2-6-manufacturing-process-development><leaf>...</leaf></m3-2-s-2-6-manufacturing-process-development>
        </m3-2-s-2-manufacture>
        <m3-2-s-3-characterisation>
          <leaf>...</leaf>
          <m3-2-s-3-1-elucidation-of-structure-and-other-characteristics><leaf>...</leaf></m3-2-s-3-1-elucidation-of-structure-and-other-characteristics>
          <m3-2-s-3-2-impurities><leaf>...</leaf></m3-2-s-3-2-impurities>
        </m3-2-s-3-characterisation>
        <m3-2-s-4-control-of-drug-substance>
          <leaf>...</leaf>
          <m3-2-s-4-1-specification><leaf>...</leaf></m3-2-s-4-1-specification>
          <m3-2-s-4-2-analytical-procedures><leaf>...</leaf></m3-2-s-4-2-analytical-procedures>
          <m3-2-s-4-3-validation-of-analytical-procedures><leaf>...</leaf></m3-2-s-4-3-validation-of-analytical-procedures>
          <m3-2-s-4-4-batch-analyses><leaf>...</leaf></m3-2-s-4-4-batch-analyses>
          <m3-2-s-4-5-justification-of-specification><leaf>...</leaf></m3-2-s-4-5-justification-of-specification>
        </m3-2-s-4-control-of-drug-substance>
        <m3-2-s-5-reference-standards-or-materials><leaf>...</leaf></m3-2-s-5-reference-standards-or-materials>
        <m3-2-s-6-container-closure-system><leaf>...</leaf></m3-2-s-6-container-closure-system>
        <m3-2-s-7-stability>
          <leaf>...</leaf>
          <m3-2-s-7-1-stability-summary-and-conclusions><leaf>...</leaf></m3-2-s-7-1-stability-summary-and-conclusions>
          <m3-2-s-7-2-post-approval-stability-protocol-and-stability-commitment><leaf>...</leaf></m3-2-s-7-2-post-approval-stability-protocol-and-stability-commitment>
          <m3-2-s-7-3-stability-data><leaf>...</leaf></m3-2-s-7-3-stability-data>
        </m3-2-s-7-stability>
      </m3-2-s-drug-substance>
      <m3-2-p-drug-product product-name="Example Product" dosageform="Tablet" manufacturer="Example Manufacturer">
        <leaf>...</leaf>
        <m3-2-p-1-description-and-composition-of-the-drug-product><leaf>...</leaf></m3-2-p-1-description-and-composition-of-the-drug-product>
        <m3-2-p-2-pharmaceutical-development><leaf>...</leaf></m3-2-p-2-pharmaceutical-development>
        <m3-2-p-3-manufacture>
          <leaf>...</leaf>
          <m3-2-p-3-1-manufacturers><leaf>...</leaf></m3-2-p-3-1-manufacturers>
          <m3-2-p-3-2-batch-formula><leaf>...</leaf></m3-2-p-3-2-batch-formula>
          <m3-2-p-3-3-description-of-manufacturing-process-and-process-controls><leaf>...</leaf></m3-2-p-3-3-description-of-manufacturing-process-and-process-controls>
          <m3-2-p-3-4-controls-of-critical-steps-and-intermediates><leaf>...</leaf></m3-2-p-3-4-controls-of-critical-steps-and-intermediates>
          <m3-2-p-3-5-process-validation-and-or-evaluation><leaf>...</leaf></m3-2-p-3-5-process-validation-and-or-evaluation>
        </m3-2-p-3-manufacture>
        <m3-2-p-4-control-of-excipients excipient="Example Excipient">
          <leaf>...</leaf>
          <m3-2-p-4-1-specifications><leaf>...</leaf></m3-2-p-4-1-specifications>
          <m3-2-p-4-2-analytical-procedures><leaf>...</leaf></m3-2-p-4-2-analytical-procedures>
          <m3-2-p-4-3-validation-of-analytical-procedures><leaf>...</leaf></m3-2-p-4-3-validation-of-analytical-procedures>
          <m3-2-p-4-4-justification-of-specifications><leaf>...</leaf></m3-2-p-4-4-justification-of-specifications>
          <m3-2-p-4-5-excipients-of-human-or-animal-origin><leaf>...</leaf></m3-2-p-4-5-excipients-of-human-or-animal-origin>
          <m3-2-p-4-6-novel-excipients><leaf>...</leaf></m3-2-p-4-6-novel-excipients>
        </m3-2-p-4-control-of-excipients>
        <m3-2-p-5-control-of-drug-product>
          <leaf>...</leaf>
          <m3-2-p-5-1-specifications><leaf>...</leaf></m3-2-p-5-1-specifications>
          <m3-2-p-5-2-analytical-procedures><leaf>...</leaf></m3-2-p-5-2-analytical-procedures>
          <m3-2-p-5-3-validation-of-analytical-procedures><leaf>...</leaf></m3-2-p-5-3-validation-of-analytical-procedures>
          <m3-2-p-5-4-batch-analyses><leaf>...</leaf></m3-2-p-5-4-batch-analyses>
          <m3-2-p-5-5-characterisation-of-impurities><leaf>...</leaf></m3-2-p-5-5-characterisation-of-impurities>
          <m3-2-p-5-6-justification-of-specifications><leaf>...</leaf></m3-2-p-5-6-justification-of-specifications>
        </m3-2-p-5-control-of-drug-product>
        <m3-2-p-6-reference-standards-or-materials><leaf>...</leaf></m3-2-p-6-reference-standards-or-materials>
        <m3-2-p-7-container-closure-system><leaf>...</leaf></m3-2-p-7-container-closure-system>
        <m3-2-p-8-stability>
          <leaf>...</leaf>
          <m3-2-p-8-1-stability-summary-and-conclusion><leaf>...</leaf></m3-2-p-8-1-stability-summary-and-conclusion>
          <m3-2-p-8-2-post-approval-stability-protocol-and-stability-commitment><leaf>...</leaf></m3-2-p-8-2-post-approval-stability-protocol-and-stability-commitment>
          <m3-2-p-8-3-stability-data><leaf>...</leaf></m3-2-p-8-3-stability-data>
        </m3-2-p-8-stability>
      </m3-2-p-drug-product>
      <m3-2-a-appendices>
        <leaf>...</leaf>
        <m3-2-a-1-facilities-and-equipment manufacturer="Example Manufacturer" substance="Example Substance"><leaf>...</leaf></m3-2-a-1-facilities-and-equipment>
        <m3-2-a-2-adventitious-agents-safety-evaluation manufacturer="Example Manufacturer" substance="Example Substance"><leaf>...</leaf></m3-2-a-2-adventitious-agents-safety-evaluation>
        <m3-2-a-3-excipients><leaf>...</leaf></m3-2-a-3-excipients>
      </m3-2-a-appendices>
      <m3-2-r-regional-information><leaf>...</leaf></m3-2-r-regional-information>
    </m3-2-body-of-data>
    <m3-3-literature-references><leaf>...</leaf></m3-3-literature-references>
  </m3-quality>

  <m4-nonclinical-study-reports>
    <leaf>...</leaf>
    <m4-2-study-reports><leaf>...</leaf><m4-2-1-pharmacology>
        <leaf>...</leaf>
        <m4-2-1-1-primary-pharmacodynamics><leaf>...</leaf></m4-2-1-1-primary-pharmacodynamics>
        <m4-2-1-2-secondary-pharmacodynamics><leaf>...</leaf></m4-2-1-2-secondary-pharmacodynamics>
        <m4-2-1-3-safety-pharmacology><leaf>...</leaf></m4-2-1-3-safety-pharmacology>
        <m4-2-1-4-pharmacodynamic-drug-interactions><leaf>...</leaf></m4-2-1-4-pharmacodynamic-drug-interactions>
      </m4-2-1-pharmacology>
      <m4-2-2-pharmacokinetics>
        <leaf>...</leaf>
        <m4-2-2-1-analytical-methods-and-validation-reports><leaf>...</leaf></m4-2-2-1-analytical-methods-and-validation-reports>
        <m4-2-2-2-absorption><leaf>...</leaf></m4-2-2-2-absorption>
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  <m5-clinical-study-reports>
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      <m5-3-7-case-report-forms-and-individual-patient-listings><leaf>...</leaf></m5-3-7-case-report-forms-and-individual-patient-listings>
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    <m5-4-literature-references><leaf>...</leaf></m5-4-literature-references>
  </m5-clinical-study-reports>

</ectd:ectd>