Addendum Reports

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Chapter: Pharmacovigilance: Periodic Safety Update Reports

The concept and use of the IBD for PSURs have not been fully accepted by all regulators.


ADDENDUM REPORTS

The concept and use of the IBD for PSURs have not been fully accepted by all regulators. Some require that PSURs are scheduled according to the local approval date. Moreover, not all companies will have synchronised their renewal dates by bringing them forward to the IBD in those countries where this is permissible. To avoid producing additional reports for those countries perceiving that any report with a DLP more than 60 days before submission is out of date, CIOMS V recommended the use of an adden-dum report. This is an update to the most recently completed, scheduled PSUR that is produced when a regulator requires a safety update outside the usual reporting cycle, and more than a brief amount of time has elapsed since the DLP of the most recent PSUR. A brief amount of time here refers to 3 months for a 6-month report, and more than 6 months for an annual or longer interval report. The addendum report therefore supplements annual or five yearly reports. CIOMS V proposed that the addendum report should follow the PSUR format but that it should contain the minimum of information.

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