Regulatory science research to develop the guidelines concerning nanotechnology-related drugs

・Points to Consider in the manufacture and testing of nanomedicines.
・Points to Consider in the evaluation of non-clinical pharmacokinetics, pharmacodynamics, and toxicology of nanomedicines.
・Consideration for First-in-Human studies of nanomedicines.


・Guideline for the Development of Liposome Drug Products　
　[March 28, 2016, PSEHB/ELD Notification No. 0328-19, English translation]

The objective of this document is to facilitate the rational development of liposome drug products and their efficiennt regulatory review by identifying the points to be considered in the development of liposome drug products, and by presenting somje examples required for the registration application. This document mainly provides information regarding the pharmaceutical development and nonclinical and early clinical studies of liposome drug products.


・Reflection Paper on Nucleic Acids (siRNA)-Loaded Nanotechnology-Based Drug Products
　[March 28, 2016, PSEHB/ELD Administrative Notice, English translation]

This reflection paper addresses some points for consideration when assessing siRNA-drug products made using nanotechnology-based carriers (hereinafter referred to as nucleic acids [siRNA]-loaded nanotechnology-based drug product). While this reflection paper discusses the points to be considered for pharmaceutical development of nucleic acids (siRNA)-loaded nanotechnology-based drug product, the principles outlined here may be applicable to the pharmaceutical development of nucleic acids other than siRNA-based products that use nanotechnology-based carriers.


・Joint MHLW/EMA Reflection Paper on the Development of Block Copolymer Micelle Medicinal Products　
　[January 10, 2014, PFSB/ELD Notification No.0110-1]
・Draft

This　paper addresses the key general principles of block copolymer micelle development, thereby allowing sponsors to scientifically justify their development strategy. This reflection paper provides basic information for the pharmaceutical development, and non-clinical and early clinical studies of such products designed to modify the pharmacokinetics, stability and distribution or incorporated or conjugated active substances in vivo.