With a view to streamline the regulatory submission procedure, the Central Drugs Standards Control Organisation (“CDSCO”) has notified that applications of Period Safety Update Reports (PSURs) with respect to Marketing Authorization of New Drugs/ Subsequent New Drugs/ Fixed Dose Combinations/ Biologicals/ Veterinary are required to be made through the online system of Sugam Portal at www.cdscoonline.gov.in.
Applicants submitting PSURs are directed to apply as per the checklist in the portal. The facility for offline submissions will not be available for processing from 11th March 2024.
A copy of the Circular is linked below for ease of reference.
Source: Central Drugs Standard Control Organisation
