Expedited Drug Review Processes for Approval in the United States and European Union with an Illustration

Abstract

Expedited approval processes push new drugs to the market faster than ever. Regulatory Authorities of the United States (US) and European Union (EU) are using different approval pathways to cut down the time it takes to conduct a clinical review. Conventional drug discovery is a costly and time-consuming process. A study found that pharmaceutical industries spend an average of $3 billion in R&D activities, and more than 10 years are required to develop and market one new drug. Patients can hardly wait 10 years for a lifesaving drug. For this reason, in the field of new drug discovery, Regulatory authorities and pharmaceutical companies are pursuing a strategy that expedites the approval of certain drugs that treat severe conditions and address unmet medical needs. Expedited approval processes could attract attention as a solution to dramatically reduce the time and cost required for the new drug discovery. In this article, it is presented with different expedited approval processes in the US and EU with an illustration of these speedy approval processes by taking Crizotinib drug for a better understanding.

Keywords: Expedited Approval; Fast Track Approval; Accelerated Approval; Breakthrough Therapy; Priority Review; Priority Medicines