The Central Drugs Standard Control Organization (CDSCO) on February 26, 2024, issued a notification regarding the Submission of online applications of PSURs w.r.t Marketing Authorization of New Drugs/SNDs/FDCs/Biologicals/Veterinary
The following has been stated namely: -
• It states that In order to streamline the regulatory submission procedure, the submission of applications of PSURs (Period Safety Update Reports) w.r.t Marketing Authorization of New Drugs/ Subsequent NewDrugs(SND/ Fixed Dose Combinations(FDC)/ Biologicals/ Veterinary is functional now through the online system of Sugam portal at www.cdscoonline.gov.in.
• All applicants submitting PSURs shall apply through online portal as per the checklist in the Portal.
• It states that The facility of offline submission of applications in hard copy or any other mode will not be available for processing from March 11, 2024.
[Notification No. PSUR-13011(14)/2/2024]
