Division of Drugs 

Japanese


The division consists of four sections engaged in research work related to chemical analysis and pharmaceutical (biological and physico-chemical) evaluation of drugs and their preparations, as well as evaluation of specifications submitted for new drug applications.


Announcement


  • Bioanalytical Method Validation
    Draft Guideline on Bioanalytical Method (Ligand Binding Assay) Validation in Pharmaceutical Development [PDF in English]New!
    Public comment seeking period: 10 Jan. 2014 - 10 Feb. 2014 (MHLW site for public comments, acceptable public comments are only in Japanese).
    Caution! : The file released before 4th Feb. was not correct!

  • Nanomedicines
    Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products, Draft (2013/2/1) [PDF]New!
    MHLW site for public consultation (only in Japanese)
    EMA site for public consultation


  • Pharmaceutical Development and GMP
    Response to the feedback on Mock P2 with Enhanced Approach(2010)
    ------English Mock QOS P2 Revised version(2010)------
    ------English Mock Application Form(2010)------
    Pharmaceutical Development P2 with Enhanced Approach(2008)
    ------Mock P2 English(FileC)(2008)------
    Draft GMP Guidelines For Comments (2004)


  • Bioequivalence
    Guideline for Bioequivalence Studies of Generic Products (2012/02/29) Updated
           GL (pdf file), Q&A (pdf file)
    Guideline for Bioequivalence Studies of Generic Products for Different Strengths of Oral Solid Dosage Forms (2012/02/29) Updated
           GL (pdf file), Q&A (pdf file)   
    Guideline for Bioequivalence Studies for Formulation Changes of Oral Solid Dosage Forms (2012/02/29) Updated   
           GL (pdf file), Q&A (pdf file)  
    Guideline for Bioequivalence Studies for Different Oral Solid Dosage Forms (2012/02/29) Updated   
           GL (pdf file), Q&A (pdf file)
    Bioequivalence Studies of Generic Products for Ethical Combination Drug Products (2012/02/29)   
           Q&A (pdf file)  
    Bioequivalence Studies for Different Strengths of Ethical Combination Drug Products and Formulation Changes of Ethical Combination Drug Products (2012/02/29)   
           Q&A (pdf file)
    Guidelines for the Design and Evaluation of Oral Prolonged Release Dosage Forms (1988/03/11)   
           GL (pdf file)
    Old Guideline


  • Others
    Bioanalytical Method Validation and related areas.
    Validation of Analytical Procedures: Methodology (1996) Step 4, Consensus Guideline (obtained from EMEA)
    Guidelines for the Design and Evaluation of Oral Prolonged Release Dosage Forms (1988) (pdf file)
    Japanease Orange Book English Version
    NIHS Nanomedicine regulatory science research
  • First Section
    Second Section
    Third Section
    Fourth Section

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    Last edition: Jul. 12, 2012