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

  • SSND Balakrishna Ch Department of Pharmaceutical Regulatory Affairs, Shri Vishnu College of Pharmacy (Autonomous), Bhimavaram -534202, Affiliated to Andhra University, Visakhapatnam, Andhra Pradesh, INDIA
  • Sai Pavan Dwarapudi Department of Pharmaceutical Regulatory Affairs, Shri Vishnu College of Pharmacy (Autonomous), Bhimavaram -534202, Affiliated to Andhra University, Visakhapatnam, Andhra Pradesh, INDIA
  • Ravi Kumar Reddy Juturi Department of Pharmaceutical Regulatory Affairs, Shri Vishnu College of Pharmacy (Autonomous), Bhimavaram -534202, Affiliated to Andhra University, Visakhapatnam, Andhra Pradesh, INDIA
  • Venkateswara Raju K Department of Pharmaceutical Regulatory Affairs, Shri Vishnu College of Pharmacy (Autonomous), Bhimavaram -534202, Affiliated to Andhra University, Visakhapatnam, Andhra Pradesh, INDIA
Keywords: Expedited Approval, Fast Track Approval, Accelerated Approval, Breakthrough Therapy, Priority Review, Priority Medicines

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.

Downloads

Download data is not yet available.
CMA, Accelerated Assessment, Exceptional Circumstances, & PRIME approvals
Published
2021-07-16
How to Cite
1.
Balakrishna Ch S, Dwarapudi SP, Juturi RKR, K VR. Expedited Drug Review Processes for Approval in the United States and European Union with an Illustration. ijpi [Internet]. 16Jul.2021 [cited 6Dec.2021];11(2):137-42. Available from: https://jpionline.org/index.php/ijpi/article/view/1024