title: How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice.
abstract: In 2010, the European Medicines Agency (EMA) initiated a pilot project on parallel scientific advice with Health Technology Assessment bodies (HTABs) that allows manufacturers to receive simultaneous feedback from both the European Union (EU) regulators and HTABs on their development plans for medicines.
  
  
  
  The present retrospective qualitative analysis aimed to explore how the parallel scientific advice system is working and levels of commonality between the EU regulators and HTABs, and among HTABs, when applicants obtain parallel scientific advice from both a regulatory and an HTA perspective.
  
  
  
  We analysed the minutes of discussion meetings held at the EMA between 2010, when parallel advice was launched, and 1 May 2015, when the cutoff date for data extraction was set. The analysis was based on predefined criteria and conducted at two different levels of comparison: the answers of the HTABs vs. those of the regulators, and between the answers of the participating HTA agencies.
  
  
  
  The analysis was based on 31 procedures of parallel scientific advice. The level of full agreements was highest for questions on patient population (77%), while disagreements reached a peak for questions on the study comparator (30%). With regard to comparisons among HTABs, there was a high level of agreement for all domains.
  
  
  
  There is evident commonality, in terms of evidence requirements between the EU regulators and participating HTABs, as well as among HTABs, on most aspects of clinical development. Indeed, regardless of the question content, the analysis showed that a high level of overall agreement was reached through the process of parallel scientific advice.
authors.affiliation: European Medicines Agency (EMA), 30 Churchill Place, London, E14 5EU, UK. giovanni.tafuri@ema.europa.eu.|Italian Medicines Agency (AIFA), via del Tritone, 181 - 00187, Rome, Italy. giovanni.tafuri@ema.europa.eu.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Tafuri
authors.affiliation: European Medicines Agency (EMA), 30 Churchill Place, London, E14 5EU, UK.
authors.forename: Margherita
authors.initials: M
authors.lastname: Pagnini
authors.affiliation: European Medicines Agency (EMA), 30 Churchill Place, London, E14 5EU, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Moseley
authors.affiliation: Italian Medicines Agency (AIFA), via del Tritone, 181 - 00187, Rome, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Massari
authors.affiliation: European Medicines Agency (EMA), 30 Churchill Place, London, E14 5EU, UK.
authors.forename: Frank
authors.initials: F
authors.lastname: Petavy
authors.affiliation: German Federal Joint Committee (G-BA), Wegelystr. 8, D-10623, Berlin, Germany.
authors.forename: Antje
authors.initials: A
authors.lastname: Behring
authors.affiliation: Catalan Agency for Health Quality and Assessment (AQuAS), Carrer de Roc Boronat 81-95, 08005, Barcelona, Spain.
authors.forename: Arantxa
authors.initials: A
authors.lastname: Catalan
authors.affiliation: National Institute for Health and Care Excellence (NICE), 10 Spring Gardens, London, SW1A 2BU, United Kingdom.
authors.forename: Elangovan
authors.initials: E
authors.lastname: Gajraj
authors.affiliation: Dental and Pharmaceutical Benefits Agency (TLV), Fleminggatan 7, 112 26, Stockholm, Sweden.
authors.forename: Niklas
authors.initials: N
authors.lastname: Hedberg
authors.affiliation: Catalan Agency for Health Quality and Assessment (AQuAS), Carrer de Roc Boronat 81-95, 08005, Barcelona, Spain.
authors.forename: Mercè
authors.initials: M
authors.lastname: Obach
authors.affiliation: National Institute for Health and Care Excellence (NICE), 10 Spring Gardens, London, SW1A 2BU, United Kingdom.
authors.forename: Leeza
authors.initials: L
authors.lastname: Osipenko
authors.affiliation: Italian Medicines Agency (AIFA), via del Tritone, 181 - 00187, Rome, Italy.
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Russo
authors.affiliation: National Institute for Sickness and Invalidity Insurance (INAMI), Avenue de Tervueren 211, 1150, Bruxelles, Belgium.
authors.forename: Marc
authors.initials: M
authors.lastname: Van De Casteele
authors.affiliation: Main Association of Austrian Social Security Institutions (HVB), Kundmanngasse 21, A-1031, Vienna, Austria.
authors.forename: Eva-Maria
authors.initials: EM
authors.lastname: Zebedin
authors.affiliation: European Medicines Agency (EMA), 30 Churchill Place, London, E14 5EU, UK.
authors.forename: Guido
authors.initials: G
authors.lastname: Rasi
authors.affiliation: European Medicines Agency (EMA), 30 Churchill Place, London, E14 5EU, UK.
authors.forename: Spiros
authors.initials: S
authors.lastname: Vamvakas
mesh_terms: D017277:Drug Approval / Q000379:methods*; D005062:European Union; D033161:Government Regulation; D006801:Humans; D015397:Program Evaluation; D013673:Technology Assessment, Biomedical
keywords: EMA; Health Technology Assessment; agreement; parallel scientific advice; regulatory