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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
King Skyfront area