ABSTRACT
The realisation of the full potential of products based on stem cells in a clinical setting demands robust scientific evidence, underpinned by legitimate regulatory requirements to ensure their safety and efficacy. This review examines the legal aspects of the use of stem cells in the laboratory and in the development of new therapies and pharmaceutical products. UK and European legal and regulatory documents and directives are used as the framework for discussion of the current status and future prospects.
Subject(s)
Ethics, Medical , Government Regulation , Health Policy/legislation & jurisprudence , Stem Cell Transplantation , Stem Cells , Animals , Europe , Humans , Stem Cell Transplantation/ethics , Stem Cell Transplantation/legislation & jurisprudenceABSTRACT
At the end of next month, the European Medicines Agency (EMEA) will implement a new legislative framework and several provisions that seek to provide incentives and streamline regulatory oversight of certain monoclonal antibodies and other biologic products.
