Post marketing surveillance is an important process to monitor safety of the approved drug. The safety of a developmental drug must also be reported from clinical trials. When there is an adverse event (AE), then it required to be reported regardless of its validity. If it is a valid case justifying minimum criteria; Identifiable patient, Identifiable drug, Identifiable event and Identifiable reporter, then it should be reported to the regulatory authorities depends upon the nature of the event. The reports should be submitted within the timelines with good quality.