title: Improving the contribution of regulatory assessment reports to health technology assessments--a collaboration between the European Medicines Agency and the European network for Health Technology Assessment.
abstract: In response to a recommendation from the Pharmaceutical Forum, the European Medicines Agency and the European network for Health Technology Assessment initiated a collaboration with the aim to improve the contribution regulatory assessment reports can make to the assessment of relative effectiveness of medicinal products by health technology assessment bodies. This collaboration on improving European Public Assessment Reports (EPARs) started in February 2010 and was performed over 2 years. As a result, the templates for preparing EPARs were revised to better address the needs of heath technology organizations. The better understanding of information needs was a key outcome of the collaboration. To ascertain whether these template changes led to the inclusion of relevant information, a review of a small set of EPARs for recently approved medicinal products was carried out in parallel by both the European network for Health Technology Assessment and the European Medicines Agency. This report provides an account of this project on improving EPARs, which is part of the ongoing dialogue between regulators and health technology assessment bodies on a European level to support policymaker decisions in the future.
authors.affiliation: European Medicines Agency, London, UK. Electronic address: michael.berntgen@ema.europa.eu.
authors.forename: Michael
authors.initials: M
authors.lastname: Berntgen
authors.affiliation: La Haute Autorité de Santé, Saint-Denis La Plaine Cedex, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Gourvil
authors.affiliation: La Haute Autorité de Santé, Saint-Denis La Plaine Cedex, France.
authors.forename: Mira
authors.initials: M
authors.lastname: Pavlovic
authors.affiliation: National Health Care Institute, Diemen, The Netherlands.
authors.forename: Wim
authors.initials: W
authors.lastname: Goettsch
authors.affiliation: European Medicines Agency, London, UK.
authors.forename: Hans-Georg
authors.initials: HG
authors.lastname: Eichler
authors.affiliation: EUnetHTA Secretariat, C/o Danish Health and Medicines Authority, Copenhagen, Denmark.
authors.forename: Finn Børlum
authors.initials: FB
authors.lastname: Kristensen
mesh_terms: D020811:Biomedical Technology / Q000458:organization & administration*; D003299:Cooperative Behavior; D005062:European Union; D006801:Humans; D011050:Policy Making; D013673:Technology Assessment, Biomedical / Q000458:organization & administration*
keywords: European Medicines Agency (EMA); European Public Assessment Reports (EPARs); European network for Health Technology Assessment (EUnetHTA); relative effectiveness assessment