Regenerative Medicine: A Snapshot of the Current Regulatory Environment and Standards

There has been an immense amount of research activity in the emerging field of regenerative medicine that dates back to the early 80's and beyond and many examples where products have made the difficult transition from the laboratory to commercially available goods. This process, like many product developments, is fraught with issues that range from identifying and realising the market needs to the challenge of raising capital. It can be argued that this transition process is even more challenging for regenerative medicine products since, in many cases the existing infrastructural network i.e. regulations and standards that support medicines and medical devices are inappropriate. Indeed this non-compliance with the existing framework is often cited as a barrier to commercialisation. Here, we review the current regulatory framework and standards portfolio and discuss the role that they have in commercialising potential regenerative medicine products. It does not cover the broader issue of regenerative medicine research itself or the economics of commercialisation.