Timing of submission was rigid (in the EU: every 6 months for 2 years, yearly for 2 years then every 3 years forever). Abstract The periodic safety update report for marketed drugs (PSUR) was designed to be a stand-alone document that allows a periodic but comprehensive assessment of the worldwide safety data of a marketed drug or biological product. PBRER requested by regulatory authority: 90 calendar days. Minimal cumulative overviewsįollow up of any Risk Management Plans in place FDA requires two type aggregated safety report Development Safety Update Report for Drug. They include an analysis and evaluation of new or changing safety data received during the period covered by the PSUR which includes:Īnalysis of ADRs & lack of efficacy cases,Īn interval data review. A PSUR covers one entity (all indications, dose forms, routes of administration and regimens). They are standardized and accepted by most health authorities (including FDA, Health Canada, the EU).
The PSURs (Periodic Safety Update Report) have been around for many years. Therefore, Periodic Safety Update Reports (PSUR) present the worldwide safety experience of a medicinal product at defined times post-authorisation, in order to. This document summarizes FDA’s position on accepting the new format EU/EMA PSURs known as PBRERs (pronounced “pee-bers”).Ī brief review of the new and old PSUR situation. 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).
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