EMA, UK NICE justify different approaches on scientific advice
This article was originally published in SRA
Executive Summary
The UK's National Institute for Health and Clinical Excellence has been making inroads into a role that has traditionally rested with drug regulators: that of giving scientific advice to pharmaceutical companies early in the drug development process. Its approach in framing this advice is, however, vastly different from that of the European Medicines Agency, which has been offering scientific advice and protocol assistance to drug companies for more than a decade1.