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

SND Balakrishna Ch1★, Sai Pavan Dwarapudi1, Ravi Kumar Reddy Juturi1, Venkateswara Raju K.1★ Corresponding author

  1. 1Department of Pharmaceutical Regulatory Affairs, Shri Vishnu College of Pharmacy (Autonomous), Bhimavaram -534202, Affiliated to Andhra University, Visakhapatnam, Andhra Pradesh, INDIA.

CORRESPONDENCE

SND Balakrishna Ch

Department of Pharmaceutical Regulatory Affairs, Shri Vishnu College of Pharmacy (Autonomous), Bhimavaram -534202, Affiliated to Andhra University, Visakhapatnam, Andhra Pradesh, INDIA.

balakrishnachilukuri@gmail.com

Received: 02-05-2021; Revised: 01-06-2021; Accepted: 18-06-2021.

Volume 11, Issue 2 · pp. 137–142 · PUBLISHED · DOI: 10.5530/ijpi.2021.2.26

View on IJPI original site ↗

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.

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    Ch, S. B., Dwarapudi, S. P., Juturi, R. K. R., & K., V. R. (). Expedited Drug Review Processes for Approval in the United States and European Union with an Illustration. International Journal of Pharmaceutical Investigation, 11(2), 137–142. https://doi.org/10.5530/ijpi.2021.2.26