Adverse event reporting, periodic safety update reports and the safety systems behind them.
Approval starts the safety obligation rather than ending it. Marketing authorisation holders are expected to collect and report adverse events, submit periodic safety update reports on schedule, and maintain a system that can demonstrate both.
India's Pharmacovigilance Programme of India collects adverse drug reaction reports through a national network, and expectations around timeliness and completeness have tightened steadily.
Case processing and reporting, PSUR preparation and submission, standard operating procedures, and the periodic review that catches a signal before someone else does.
Tell us the molecule, the indication and where you are in the process. We will tell you what the realistic path and timeline look like.
Talk to our regulatory team