The Changing European Regulatory Landscape

Whilst the US has traditionally been considered the Agency that sets the gold standard for medicines regulation, with the increasing demand for global cooperation and harmonisation of technical conformity and regulatory control, consideration should be given to regulatory requirements in jurisdictions other than the US. The European Union is becoming an important region for global product development. This review sets out scientific and public policy aspects that underpin the European legislative framework for certain healthcare products, including those derived from novel technological platforms. This review attempts to highlight some of the current and new challenges to the development of biotechnological and emerging technology products. There seems little doubt that the whole area of regulatory laws and policy will present new challenges to companies and their advisors in the coming years.