The Central Drugs Standard Control Organization vide its notification dated 25th February 2021 has directed the stakeholders to avail the facility of online submission of SAE reports.
As per “The New Drugs and Clinical Trials Rules, 2019”, Investigator, Sponsor/CT-NOC Holder and Ethics Committee shall report all Serious Adverse Events (SAE’s)to the Central Licensing Authority within a prescribed time bound manner as specified in Rule 42 of the said rules.
However after the implementation of “SUGAM” portal, all the reports of serious adverse events hall be filed through this portal with effect from 14th March 2021 and from this date physical/offline files of SAE reports may not be accepted for processing.
