What can be learnt from the Japanese regulatory approach to tissue engineered products?
The Japanese government has recognized the challenges its rapidly aging population presents, especially in terms of healthcare provision, and is focusing on the potential of regenerative medicine to address them. The country has consequently embarked upon a national program to support development of this field. In 1999 Japan initiated a national research project in science and technology, known as the Millennium Project, whose areas of research include tissue engineering covering skin, cornea, bone, cartilage, blood vessels, nerves and bone marrow. In this context, at a time when regulations for tissue engineered products are being developed and revised in the USA and at the European level, it is interesting to investigate what type of framework Japanese regulators have designed to deal with these products in order to see what lessons might be learnt by UK, US and EU regulators. This paper reviews negative and positive aspects of the current regulatory situation that applies to tissue engineered products in Japan but will mostly focus on examples of good practice, such as the pragmatism that underpins the Japanese regulatory strategy, the international involvement of the country when it comes to developing regulatory standards and the promotion of a supportive public environment.
Cambridge University, Centre for Economics and Policy, Institute for Manufacturing, Department of Engineering, 16 Mill Lane, Cambridge, CB2 1RX, UK. ld308@cam.ac.uk
Laure
L
Brévignon-Dodin
Finbarr
F
Livesey
D018795:Device Approval; D017277:Drug Approval; D033161:Government Regulation; D006801:Humans; D007564:Japan; D016730:Program Development; D015397:Program Evaluation; D011639:Public Opinion; D044968:Regenerative Medicine / Q000331:legislation & jurisprudence* / Q000639:trends*; D023822:Tissue Engineering / Q000295:instrumentation / Q000331:legislation & jurisprudence* / Q000639:trends*