International Journal of Pharmaceutical Investigation, 2021, 11, 2, 137-142.
DOI: 10.5530/ijpi.2021.2.26
Published: July 2021
Type: Review Article
Authors:
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
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