CPhI expert calls for ANDA approval times to be reduced to help lower drug costs

The necessity of time reduction for Abbreviated New Drug Application (ANDA) approvals, was addressed by Girish Malhotra, President of Epcot International and CPhI Worldwide Annual Industry Report member, arguing that, if the current approval time can be reduced from 10 months to threemonths, drug costs will decrease.

Mr Malhotra states that in order to decrease the time for ANDA approvals, there are three main challenges to overcome. Currently, it takes up to four review cycles to approve an ANDA, and the first and foremost challenge is with submission completeness. On average, it takes the Food and Drug Administration reviewing team 45 days to determine application completeness. This time can potentially be reduced to 15 days if the FDA modifies its review process. Last month the Pre-ANDA program was proposed, a first-step Quality by Analysis (QbA) implementation in the application filing process. Although applications for every product are different in content, the information filing requirements are essentially the same.

For example, a template application that covers 90% of the filing requirements can be designed whereby a standard format could reduce four reviews to a single review. However, to avoid confusion and delay, the FDA would have to create applications that clearly state what is expected from companies; this must then be transformed into a standard template.