BE-NOC Prior Intimation (System of Notification for certain category of new drugs for conduct of “BA-BE Studies” for export purpose under Chapter V, NDCT Rule, 2019) and procedure for obtaining CT-16 application on NSWS Portal

The CDSCO, through a notice dated 22 May 2026, addressed operational challenges related to the absence of system linkage between Prior Intimation (Form CT05) and CT16 applications.   To facilitate uninterrupted regulatory processing, applicants intending to import Reference Listed Drugs (RLD) or Investigational Medicinal Products (IMP) for bioavailability/ bioequivalence (BA/BE) studies for export are required to submit standalone CT16 applications through the National Single Window System (NSWS).   The application must include a covering letter, acknowledged CT05 copy, product details, protocol or reference information, fee challan, and other supporting documents. This measure is temporary and does not waive compliance with the New Drugs and Clinical Trials Rules, 2019. CDSCO offices have been directed to prioritize such applications until further notice.