The changing European regulatory landscape: Present and future challenges to the development of biotechnological and emerging technology products

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. It should be recognised that the development of high technology products is more costly and carries higher business risks compared with conventional pharmaceutical products. A successful product development should therefore be underpinned by not only good science, but a thorough understanding of the regulatory environment, which is increasingly complex. The development programme should integrate regulatory strategy at the early stages. This will help identify, address and manage potential regulatory risks that will greatly facilitate the progress of research and development, and the timeliness of the commercial launch of a product.