Comments invited on joint EU-Japan reflection paper on medicines delivered using nano-sized block copolymer micelles
The European Medicines Agency and the Japanese Ministry of Health, Labour and Welfare (MHLW) have launched a public consultation on a joint reflection paper on the development of block-copolymer-micelle medicinal products .
Nanotechnology, or the use of tiny structures, is an emerging field in science which can be used in a wide range of applications, from consumer goods to health products.
Block copolymer micelles are structures of nano-scale size which can be utilised to encapsulate medicinal products and allow improved delivery of poorly soluble or unstable products. Importantly, these structures may also enable a preferential distribution of the medicine in the human body and then contribute to an improved benefit-risk balance of the encapsulated product. In particular, block copolymer micelles have been shown to preferentially accumulate in solid tumours.
Several block-copolymer-micelle medicinal products are currently in preclinical or clinical development. This reflection paper, which intends to support innovation in the emerging field of nanotechnology-based medicines by providing guidance at very early stages of development, discusses the general principles for assessing block-copolymer-micelle products. It 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.
This reflection paper was initiated in late 2011 in the context of regular international regulators' meetings on nanomedicines chaired by the Agency. It was progressed within the framework of the confidentiality arrangement between the Agency and Japanese authorities.