Simplify & Digitize approval to conduct Bio-Equivalence and Bio-Availability study
Reform IDF268
DescriptionThe application process for conducting BE and BA studies was manual, time-consuming, and involved multiple layers of approvals, causing delays for pharmaceutical companies. The absence of a digital workflow reduced transparency and increased administrative burden.
DepartmentDrug Regulatory Authority of Pakistan - DRAP
Jurisdiction / LocationFederal - Entire Pakistan
SectorPharmaceuticals and Healthcare
Start Date18-08-2025
Target Deadline19-11-2025
Date Enacted
Implementation StatusIn Progress
Progress 50%
CCORR DirectionSimplify & Digitize
Cost Savings PKR (Mil.)
Evidence