The Central Drugs Standard Control Organization (CDSCO) has launched an Online Portal for submission of applications of Period Safety Update Reports (PSURs) with respect to Marketing Authorisations (MA) of New Drugs, Subsequent New Drugs (SNDs), Fixed Dose Combinations (FDCs), Biologicals and Veterinary. A circular on this launch was issued on February 26, 2024.
The submission of these online applications has now been made functional on the SUGAM portal.
All applicants submitting PSURs shall utilise the checklist available on the portal to submit their online applications.
It is pertinent to note that the facility for offline submission of these applications will be not permitted from March 11, 2024. Hence, no submissions in hardcopy or any other mode will be permitted after that date.
