Division of Drugs

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

Pharmaceutical Development and Quality Assurance

Continuous Manufacturing
Points to Consider Regarding Continuous Manufacturing (May. 2017) .
______(The English part begins from p.10. )

State of Control in Continuous Pharmaceutical Manufacturing (May. 2018) . NEW!
______(The English part begins from p.7. )

Sakura Bloom Tablets: Mock-up
Sakura Bloom Tablets P2 Mock (Feb. 2015) .　
Approval Application Form Mock-up (Feb. 2017) . NEW!

-------Explanation & Comments

Sakura Tablets: Mock-up
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

Nanomedicines

Guideline for the Development of Liposome Drug Products NEW!

      [March 28, 2016, PSEHB/ELD Notification No. 0328-19, English translation]
Reflection Paper on Nucleic Acids (siRNA)-Loaded Nanotechnology-Based Drug Products NEW!

      [March 28, 2016, PSEHB/ELD Administrative Notice, English translation]
Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products

      [January 10, 2014, PFSB/ELS Notification No.0110-1]
            MHLW site for public consultation (only in Japanese)

            EMA site for public consultation

Bioanalytical Method Validation

Guideline on Bioanalytical Method (Ligand Binding Assay) Validation in Pharmaceutical Development
（Japanese／Q&A／English）

Guideline on Bioanalytical Method Validation in Pharmaceutical Development (25 July 2013, MHLW, Japan)
（Japanese／Q&A／English）

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: May. 29, 2018