In the AMWA workshop entitled Regulatory Aspects of the Drug Development Process , we provide to medical writers who are relatively new to the pharmaceutical industry an overview of the drug development process. We review the US and European regulations that govern drug approval, focusing on the similarities in and differences between the registration packages filed in the United States and in Europe. We have chosen to devote this chapter to ICH because of its fundamental importance to the future direction of the pharmaceutical industry.
Various disclaimers apply.