Periodic Safety Update Report (PSURs)

Periodic Safety Update Report (PSURs): Important Considerations


Periodic safety update reports (PSUR) are pharmacovigilance documents that allow a periodic but comprehensive assessment of the risk-benefit balance of a medicinal product after it is marketed. The main purpose of the PSUR is to identify new or emerging safety information, as a means of determining changes in the benefit-risk profile of the authorised drug. Periodic safety update reports are an effective mode of risk communication to the regulatory authorities and an important indicator for the requirement of risk management strategies.

Periodic safety updates reports: The procedure as per the “New Drugs and Clinical Trials Rules, 2019”

The applicant has to provide PSURs to report all relevant new information from appropriate sources and relate the data to patient exposure. The market authorisation status in different countries and any significant safety variations observed should be summarised. The applicant has to indicate whether alterations would be made to product information in order to optimise the use of product. All dosage forms and formulations as well as indications for new drugs can be covered under one periodic safety update report. Within the single PSURs data for different dosage forms, indications or separate population have to be mentioned separately. All pertinent clinical as well as non-clinical safety data should be covered only for the period of the report.

Periodic safety update reports (PSURs): Submission

After approval of the drug is granted, for the initial two years, PSURs should be submitted every six months. For the subsequent two years, PSURs have to be submitted yearly. If deemed necessary (with regards to public health) by the central licencing authority, the total duration of submission can be extended. Periodic safety update reports which are due for a certain time frame should be submitted within thirty calendar days of the last day of the reporting period. An exception to this are cases involving serious unexpected adverse reactions; such cases must be reported to the licencing authority within fifteen days of initial receipt of the information by the applicant. The PSUR should be structured as specified in the fifth schedule (Post market assessment) of the New Drugs and Clinical Trials Rules, 2019.

Reference

New Drugs and Clinical Trials Rules, 2019, Ministry of Health & Fam. Welfare, Notification, G.S.R. 227(E), (March 19, 2019).

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Periodic Safety Update Report (PSURs)

Periodic safety update reports (PSUR) are pharmacovigilance documents that allow a periodic but comprehensive assessment of the risk-benefit balance of a medicinal product after it is marketed. The main purpose of the PSUR is to identify new or emerging safety information, as a means of determining changes in the benefit-risk profile of the authorised drug.

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