title: Transparency in drug regulation: public assessment reports in Europe and Australia.
abstract: Openness and transparency are important considerations for medicines regulators, where public health is of paramount concern. As part of their commitment to transparency, the European Medicines Agency (EMA) and Therapeutic Goods Administration (TGA) in Australia publish information relating to their evaluation of medicines via public assessment reports. European Public Assessment Reports (EPARs) and Australian Public Assessment Reports (AusPARs) provide information about the considerations that led the regulator to approve or refuse the application. The reports summarise assessments by each regulator of the information provided on the quality, safety, and efficacy of the medicine under evaluation. Here, we describe the experiences of two established medicines regulators in publishing public assessment reports, and reflect on their future role in communicating medicines information.
authors.affiliation: Therapeutic Goods Administration, Regulatory Services Group, Department of Health, 136 Narrabundah Lane, Symonston, ACT 2609, Australia. Electronic address: peter.papathanasiou@gmail.com.
authors.forename: Peter
authors.initials: P
authors.lastname: Papathanasiou
authors.affiliation: European Medicines Agency, 30 Churchill Place, Canary Wharf, London E14 5 EU, UK.
authors.forename: Laurent
authors.initials: L
authors.lastname: Brassart
authors.affiliation: European Medicines Agency, 30 Churchill Place, Canary Wharf, London E14 5 EU, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Blake
authors.affiliation: Therapeutic Goods Administration, Regulatory Services Group, Department of Health, 136 Narrabundah Lane, Symonston, ACT 2609, Australia.
authors.forename: Anna
authors.initials: A
authors.lastname: Hart
authors.affiliation: Therapeutic Goods Administration, Regulatory Services Group, Department of Health, 136 Narrabundah Lane, Symonston, ACT 2609, Australia.
authors.forename: Lel
authors.initials: L
authors.lastname: Whitbread
authors.affiliation: Therapeutic Goods Administration, Regulatory Services Group, Department of Health, 136 Narrabundah Lane, Symonston, ACT 2609, Australia.
authors.forename: Richard
authors.initials: R
authors.lastname: Pembrey
authors.affiliation: European Medicines Agency, 30 Churchill Place, Canary Wharf, London E14 5 EU, UK. Electronic address: jill.kieffer@ema.europa.eu.
authors.forename: Jill
authors.initials: J
authors.lastname: Kieffer
mesh_terms: D001315:Australia; D003142:Communication; D003256:Community Participation; D004335:Drug and Narcotic Control; D005060:Europe; D006801:Humans