Trends in orphan medicinal products approvals in the European Union between 2010–2022

被引：0
|
作者：
Luísa Bouwman
Bruno Sepodes
Hubert Leufkens
Carla Torre
机构：
[1] Universidade de Lisboa,Faculdade de Farmácia
[2] Research Institute for Medicines of the University of Lisbon (iMED.ULisboa),Laboratory of Systems Integration Pharmacology, Clinical and Regulatory Science
[3] Utrecht University,Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS)
来源：
Orphanet Journal of Rare Diseases | / 19卷
关键词：
Orphan regulation; Rare diseases; Orphan medicines; Accelerated assessment; Incentives;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
引用
收藏
相关论文
共 50 条
  • [1] Trends in orphan medicinal products approvals in the European Union between 2010-2022
    Bouwman, Luisa
    Sepodes, Bruno
    Leufkens, Hubert
    Torre, Carla
    ORPHANET JOURNAL OF RARE DISEASES, 2024, 19 (01)
  • [2] LEGAL INSTRUMENTS SUPPORTING THE DEVELOPMENT OF ORPHAN MEDICINAL PRODUCTS IN THE EUROPEAN UNION
    Miaskowska-Daszkiewicz, Katarzyna
    ACTA POLONIAE PHARMACEUTICA, 2014, 71 (01): : 181 - 187
  • [3] Evaluation of orphan maintained biological medicinal products in the European Union between 2018 to 2023: a regulatory perspective
    Caferra, Paolo
    Fraisse, Thomas
    Trincavelli, Maria Letizia
    Marchetti, Laura
    Piras, Anna Maria
    EXPERT OPINION ON BIOLOGICAL THERAPY, 2024, 24 (11) : 1279 - 1297
  • [4] European incentives for orphan medicinal products
    Enzmann, H.
    Luetz, J.
    BUNDESGESUNDHEITSBLATT-GESUNDHEITSFORSCHUNG-GESUNDHEITSSCHUTZ, 2008, 51 (05) : 500 - 508
  • [5] MEDICINAL PRODUCTS IN THE EUROPEAN UNION - BETWEEN HARMONIZATION AND DIVERGENCE
    Lojko, Natalia
    MEDICINE AND LAW, 2010, 29 (01): : 61 - 76
  • [6] ANALYSIS OF ORPHAN DRUG DESIGNATIONS AND APPROVALS IN THE UNITED STATES AND THE EUROPEAN UNION
    Almutairi, R. D.
    Alghamdi, A. A.
    Felemban, D. F.
    Seoane-Vazquez, E.
    Rodriguez-Monguio, R.
    Szeinbach, S. L.
    VALUE IN HEALTH, 2013, 16 (03) : A124 - A124
  • [7] The European challenges of funding orphan medicinal products
    Márta Szegedi
    Tamás Zelei
    Francis Arickx
    Anna Bucsics
    Emanuelle Cohn-Zanchetta
    Jurij Fürst
    Maria Kamusheva
    Pawel Kawalec
    Guenka Petrova
    Juraj Slaby
    Ewa Stawowczyk
    Milan Vocelka
    Ingrid Zechmeister-Koss
    Zoltán Kaló
    Mária Judit Molnár
    Orphanet Journal of Rare Diseases, 13
  • [8] The European challenges of funding orphan medicinal products
    Szegedi, Marta
    Zelei, Tamas
    Arickx, Francis
    Bucsics, Anna
    Cohn-Zanchetta, Emanuelle
    Furst, Jurij
    Kamusheva, Maria
    Kawalec, Pawel
    Petrova, Guenka
    Slaby, Juraj
    Stawowczyk, Ewa
    Vocelka, Milan
    Zechmeister-Koss, Ingrid
    Kalo, Zoltan
    Molnar, Maria Judit
    ORPHANET JOURNAL OF RARE DISEASES, 2018, 13
  • [9] European and Italian regulation on orphan medicinal products
    Joppi, Roberta
    FARMECONOMIA-HEALTH ECONOMICS AND THERAPEUTIC PATHWAYS, 2013, 14 (02) : 89 - 98
  • [10] SIGNIFICANT BENEFIT AND RELATIVE EFFECTIVENESS ASSESSMENT OF ORPHAN MEDICINAL PRODUCTS IN THE EUROPEAN UNION: A COMPARATIVE ANALYSIS
    de Ruijter, A.
    Sidiropoulos, I
    Larsson, K.
    Vreman, R.
    Berntgen, M.
    Goettsch, W.
    VALUE IN HEALTH, 2018, 21 : S466 - S466
12345