Pmda - Pharmaceuticals and Medical Devices Agency

Regulatory Science/The Science Board/Standard Development

Nanomedicine Initiative WG

About this WG

Nanotechnology-based medicines are anticipating to improve the benefit-risk balance of drugs. In this WG, point to consider for regulatory requirements for nanomedicine development is discussed.

What we did

  • Assisted to prepare "Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products" by the collaborative working of MHLW and EMA.

Several block copolymer micelle medicinal products are now under clinical or non-clinical developmental phases. To facilitate more appropriate development of nanotechnology-based medicines, the draft reflection paper was made. The draft reflection paper discusses the general principles for assessing block copolymer micelle medicinal products in non-clinical and early clinical studies. MHLW and EMA have invited comments on the draft reflection paper to the public.

  • Assisted MHLW to prepare two management guidance on Clinical Trial Notification contained the points to consider in the case of some nanotechnology-based medicines. (PFSB/ELD Notification No.05314 dated May 31, 2013 and PFSB/ELD Notification No.05318 dated May 31, 2013. Both are available only in Japanese.)


June, 2011


Office of New Drug I to V
Office of Vaccines and Blood Products
Office of Generic Drugs
Office of Regulatory Science Coordination