Human tissue engineered products—drugs or devices?

The new Medicines and Healthcare products Regulatory Agency (MHRA) came into existence in the United Kingdom on 1 April 2003. The new agency is the result of the merger of the Medicines Control Agency and the Medical Devices Agency, which have statutory responsibility for the regulation of medicines and medical devices. The merged body does not have new powers and leaves the existing statutory basis of regulation unchanged. Systems of licensing medicines and the control of medical devices will continue as before, but the merger is seen in the Department of Health as strengthening public protection in the context of “growing numbers of products that cross the borderline between medicines and devices.”1 The regulatory status of borderline technologies is uncertain, and acknowledgement of this is highly important for the control of regenerative medicine.

Industry, academic science and engineering, and governments are promoting tissue engineered technologies. In the United Kingdom several research councils are supporting a national centre for tissue engineering research, and other research centres are mushrooming. As a form of regenerative medicine, human tissue engineered technologies may offer notable benefits to patients in longevity, biocompatibility, and performance of implants. Expectations and hopes are high.2 The technologies combine …