Aggregate analysis of regulatory authority assessors' comments to improve the quality of periodic safety update reports

作者：Jullian Sandra^*; Jaskiewicz Lukasz; Pfannkuche Hans Juergen; Parker Jeremy; Lalande Luesink Isabelle; Lewis David J; Close Philippe

来源：Pharmacoepidemiology and Drug Safety, 2015, 24(9): 971-979.

DOI：10.1002/pds.3818

• periodic safety update report
• periodic benefit-risk evaluation report
• health authority assessment report
• pharmacovigilance
• European medicines agency
• pharmacovigilance risk assessment committee

PurposeMarketing authorization holders (MAHs) are expected to provide high-quality periodic safety update reports (PSURs) on their pharmaceutical products to health authorities (HAs). We present a novel instrument aiming at improving quality of PSURs based on standardized analysis of PSUR assessment reports (ARs) received from the European Union HAs across products and therapeutic areas.
MethodsAll HA comments were classified into one of three categories: Request for regulatory actions, Request for medical and scientific information, or Data deficiencies. The comments were graded according to their impact on patients' safety, the drug's benefit-risk profile, and the MAH's pharmacovigilance system.
ResultsA total of 476 comments were identified through the analysis of 63 PSUR HA ARs received in 2013 and 2014; 47 (10%) were classified as Requests for regulatory actions, 309 (65%) as Requests for medical and scientific information, and 118 (25%) comments were related to Data deficiencies. The most frequent comments were requests for labeling changes (35 HA comments in 19 ARs). The aggregate analysis revealed commonly raised issues and prompted changes of the MAH's procedures related to the preparation of PSURs.
ConclusionThe authors believe that this novel instrument based on the evaluation of PSUR HA ARs serves as a valuable mechanism to enhance the quality of PSURs and decisions about optimization of the use of the products and, therefore, contributes to improve further the MAH's pharmacovigilance system and patient safety.

• 出版日期2015-9