International cooperation in this field

・MHLW experts participate in discussions with international partners on issues concerning　nanomedicines (International Pharmaceutical Regulators Forum [IPRF], Nanomedicines Working Group). They attended the 1st International Workshop on Nanomedicines at EMA on 2-3　September 2010 and gave a presentation on Japan’s regulation of nanomedicines. A web-sharing training session on block copolymer micelles by Dr. Kataoka, Professor of the University of Tokyo, was held on 29 November 2011.

・MHLW and EMA began to develop a reflection paper on block copolymer micelles in 2011. 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.

・Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products　
　[January 10, 2014, PFSB/ELD Notification No.0110-1]
・Draft

Related publication in the scientific journal
・“Next-generation nanomedicines and nanosimilars: EU regulators’ initiatives relating to the development and evaluation of nanomedicines”. Nanomedicine (Lond). 8, 849-856 (2013).