Abstract

THE ROLE OF PERIODIC/REGULAR SAFETY UPDATE REPORTS IN BIOPHARMACEUTICAL SAFETY MANAGEMENT

*Atharva Bharat Karale and Vinod Patil

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Abstract

Purpose: Describes and evaluates the results of Biopharmaceuticals Periodic Safety Update Report (PSUR) assessment. Methods: A crosssectional Analysis of follow - up requests to PSURs for centrally approved biopharmaceuticals in the European Union, submitted between 1 July 2008 and 30 June 2010, was performed and PSURs were also conducted. Results: The Cross- sectional Analysis consisting or comprised of 70 Spurs‟ the total PSURs, 57(83%) identified safety concerns and 26(37%) concluded that he needed to change the Summary of the Product Characteristics (SPC) when was compared to newer devices, or older approved devices had significantly fewer potential safety concerns (60 Vs 92%; p less than 0).01) Fewer SPC changes required (15 vs 46%p 00.07). Multiple PSURs were submitted for 45 products that can be included in a follow -up Analysis. Of the 106 newly identified safety protocols for this subset of products, 7(7%) of safety issues caused labeling requirements to change in the following PSURs. Conclusions: PSUR facilitates communication between regulators and marketing Authorization Holders. Potential Safety Concerns arise for most Biopharmaceuticals and their entire life cycle, but for established products, SUR Assessments rarely leads to regulatory action.

Keywords: Periodic Safety Update Reports, Summary of Product Characteristics (SPC), Biopharmaceuticals, Safety.