title: Aggregate analysis of regulatory authority assessors' comments to improve the quality of periodic safety update reports.
abstract: OBJECTIVE
  Marketing 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.
  
  
  METHODS
  All 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.
  
  
  RESULTS
  A 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.
  
  
  CONCLUSIONS
  The 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.
authors.affiliation: Drug Safety and Epidemiology, Novartis Pharma AG, Basel, Switzerland.
authors.forename: Sandra
authors.identifier: http://orcid.org/0000-0003-3298-0472
authors.initials: S
authors.lastname: Jullian
authors.affiliation: Drug Safety and Epidemiology, Novartis Pharma AG, Basel, Switzerland.
authors.forename: Lukasz
authors.initials: L
authors.lastname: Jaskiewicz
authors.affiliation: Drug Safety and Epidemiology, Novartis Pharma AG, Basel, Switzerland.
authors.forename: Hans-Jürgen
authors.initials: HJ
authors.lastname: Pfannkuche
authors.affiliation: Drug Safety and Epidemiology, Novartis Pharma AG, Basel, Switzerland.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Parker
authors.affiliation: Drug Safety and Epidemiology, Novartis Pharma AG, Basel, Switzerland.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Lalande-Luesink
authors.affiliation: Drug Safety and Epidemiology, Novartis Pharma AG, Basel, Switzerland.|School of Life and Medical Sciences, University of Hertfordshire, Hatfield, England.
authors.forename: David J
authors.initials: DJ
authors.lastname: Lewis
authors.affiliation: European Qualified Person for Pharmacovigilance, Novartis Pharma Produktions GmbH, Wehr, Germany.|Chief Medical Office, Novartis Pharma AG, Basel, Switzerland.
authors.forename: Philippe
authors.initials: P
authors.lastname: Close
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards* / Q000706:statistics & numerical data; D005062:European Union; D006801:Humans; D061214:Patient Safety / Q000592:standards* / Q000706:statistics & numerical data; D004364:Pharmaceutical Preparations / Q000592:standards*; D060735:Pharmacovigilance; D010865:Pilot Projects; D058028:Research Report / Q000592:standards*; D013223:Statistics as Topic / Q000379:methods*
chemical_list: D004364:Pharmaceutical Preparations
keywords: European medicines agency; health authority assessment report; periodic benefit-risk evaluation report; periodic safety update report; pharmacovigilance; pharmacovigilance risk assessment committee