Division of Drugs|National Institute of Health Sciences

Lab Projects

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.

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)
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)
---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)

Bioequivalence

Guideline for Bioequivalence Studies of Generic Products: GL, Q&A (Mar. 2020)

Guideline for Bioequivalence Studies of Generic Products for Different Strengths of Oral Solid Dosage Forms: GL, Q&A (Mar. 2020)

Guideline for Bioequivalence Studies for Formulation Changes of Oral Solid Dosage Forms: GL, Q&A (Mar. 2020)

Guideline for Bioequivalence Studies for Different Oral Solid Dosage Forms: GL, Q&A (Mar. 2020)

Bioequivalence Studies of Generic Products for Ethical Combination Drug Products: Q&A (Feb. 2012)

Bioequivalence Studies for Different Strengths of Ethical Combination Drug Products and Formulation Changes of Ethical Combination Drug Products: Q&A (Feb. 2012)

Guidelines for the Design and Evaluation of Oral Prolonged Release Dosage Forms: GL (Mar. 1988)

Basic Principles on Bioequivalence Evaluation of Generic Dry Powder Inhalers: BP (Mar. 2016)

Basic Principles on Bioequivalence Studies of Generic Ophthalmic Dosage Forms: BP (Nov. 2018)

Old guidelines

Japanease Orange Book English Version

Nanomedicine

Guideline for the Development of Liposome Drug Products: PSEHB/ELD Notification No.0328-19 (Mar. 2016)

Reflection Paper on Nucleic Acids (siRNA)-Loaded Nanotechnology-Based Drug Products: PSEHB/ELD Administrative Notice (Mar. 2016)

Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products: PFSB/ELS Notification No.0110-1 (Jan. 2014)

Bioanalytical Method Validation

Guideline on Bioanalytical Method (Ligand Binding Assay) Validation in Pharmaceutical Development: GL, Q&A (May. 2014)

Reflection Paper on Nucleic Acids (siRNA)-Loaded Nanotechnology-Based Drug Products: GL, Q&A (Sep. 2013)

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Division of Drugs, National Institute of Health Sciences

3-25-26 Tonomachi, Kawasaki-ku, Kawasaki-city, Kanagawa 210-9501, Japan
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