The new pharmaceutical regulatory procedures for Europe

Since the late 1980s there has been considerable debate and discussion over the so called 'future system proposals' for the regulation of additional products throughout the European Union. On 1 January 1995 the future system became the new system with the coming into force of the Council and the associated Commission directives. These proposals are complex and have evolved from the present procedures that originated in 1965. David Jefferys gives an overview of the new procedures and considers how they will affect both the regulation of medicines and the development of new products over the rest of this decade.