Harmonizing marketing approval of generic drugs in Europe: Regulatory agencies in Europe are working to harmonize the marketing approval pathway of generic medicines

被引：0
|
作者：
Milmo, Sean [1 ]
机构：
[1] Essex, United Kingdom
来源：
Pharmaceutical Technology | 2014年 / 38卷 / 10期
关键词：
D O I：
暂无
中图分类号：
学科分类号：
摘要：
引用
收藏
页码：22 / 24
相关论文
共 21 条
  • [1] Successful generic drug product development:From research to marketing approval
    Suchart Chongprasert
    AsianJournalofPharmaceuticalSciences, 2016, 11 (01) : 35 - 36
  • [2] Generic substitution of statins: does marketing approval of first atorvastatin's generic lead to reports to other statins?
    Guillot, I.
    Bourrel, R.
    Montastruc, J. L.
    Oustric, S.
    Birebent, J.
    Sommet, A.
    FUNDAMENTAL & CLINICAL PHARMACOLOGY, 2014, 28 : 101 - 101
  • [3] Use of the Conditional Marketing Authorization Pathway for Oncology Medicines in Europe
    Hoekman, J.
    Boon, W. P. C.
    Bouvy, J. C.
    Ebbers, H. C.
    de Jong, J. P.
    De Bruin, M. L.
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2015, 98 (05) : 534 - 541
  • [4] Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021
    Vokinger, Kerstin N.
    Kesselheim, Aaron S.
    Glaus, Camille E. G.
    Hwang, Thomas J.
    JAMA HEALTH FORUM, 2022, 3 (08): : e222685
  • [5] INTERNATIONAL-COOPERATION IN DRUG-EVALUATION AND MARKETING APPROVAL IN WESTERN-EUROPE
    GRIFFIN, JP
    LONG, JR
    PHARMACY INTERNATIONAL, 1982, 3 (05): : 153 - 158
  • [6] Analysis of the evolution of the price of oncology drugs after the loss of their patent and the marketing of generic medicines
    Martinez-Sesmero, Jose M.
    Smith, Borja
    Madurga, Julen
    GLOBAL & REGIONAL HEALTH TECHNOLOGY ASSESSMENT, 2022, 9 : 68 - 72
  • [7] Regulatory approval pathway for COVID-19 vaccine in USA, Europe and India
    Narasimhan, Jaipratap
    Maanvizhi, Saba
    ANNALS OF MEDICINE AND SURGERY, 2023, 85 (04): : 860 - 867
  • [8] When Do Regulatory Agencies Request Post-approval Registries for New Medicines? A Retrospective Review of Centrally Approved Products in Europe
    Jonker, Carla J.
    van den Berg, Marijke H. M.
    Hoes, Arno W.
    Mol, Peter G. M.
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2015, 24 : 432 - 432
  • [9] New antirheumatic drugs: any real added value? A critical overview of regulatory criteria for their marketing approval
    Bertele', Vittorio
    Assisi, Alessandro
    Di Muzio, Valeria
    Renzo, Danila
    Garattini, Silvio
    EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY, 2007, 63 (09) : 879 - 889
  • [10] New antirheumatic drugs: any real added value? A critical overview of regulatory criteria for their marketing approval
    Vittorio Bertele’
    Alessandro Assisi
    Valeria Di Muzio
    Danila Renzo
    Silvio Garattini
    European Journal of Clinical Pharmacology, 2007, 63 : 879 - 889
123