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

Bioanalytical Method Validation

Draft Guideline on Bioanalytical Method Validation in Pharmaceutical Development (LC, small molecule) [PDF English, Japanese]New!

Public comment seeking period: 05 April 2013 - 04 June 2013 (MHLW site for public comments, acceptable public comments are only in Japanese).

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)