The Periodic Safety Update Report (PSUR) is a document summarising the results and conclusions of the analysis of Post-Market Surveillance (PMS) data with usage data. The purpose of the PSUR is to track the conclusions of the benefit-risk determination, the main findings of the Post-Market Clinical Follow-Up (PMCF) and the volume of sales throughout the lifetime of the device concerned. The development safety update report (DSUR) proposed in this guidance is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are under. In April 2013 FDA issued a brief guidance entitled Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report). This document summarizes FDA’s position on accepting the new format EU/EMA PSURs known as PBRERs (pronounced “pee-bers”). This refers to ICSRs (individual case safety reports) that involve a serious and unlisted event (an event not described in the drug's labeling) that is considered related to the use of the drug (US FDA).
PharmaceuticalsRegulatory AffairsPostmarket Safety
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Effective date: May 23, 2018
Foreword
Periodic Safety Update Report Example
Guidance documents are meant to provide assistance on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.
Fda Periodic Safety Update Reports
Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.
As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.
This document should be read in conjunction with relevant sections of other applicable guidance documents.