Adaptive licensing - A way forward in the approval process of new therapeutic agents in Europe

Clinical Trials and Regulatory Science in Cardiology

Volumn 1, Issue , 2015, Pages 1-2

  Rosano, Giuseppe M C ^a   Anker, Stefan D ^b   Marrocco, Walter ^c   Coats, Andrew J S ^d  

^a ST GEORGE'S UNIVERSITY OF LONDON   (United Kingdom)

^b UNIVERSITY OF GÖTTINGEN   (Germany)

^c Federazione Italiana Medici di Famiglia   (Italy)

^d MONASH UNIVERSITY   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

ADAPTIVE LICENSING; COMPASSIONATE USE; DRUG APPROVAL; DRUG DEVELOPMENT; EDITORIAL; EUROPE; HUMAN; INTERVENTION STUDY; MARKETING; OPEN STUDY; PRIORITY JOURNAL; RISK MANAGEMENT;

EID: 84930625503     PISSN: None     EISSN: 24055875     Source Type: Journal    
DOI: 10.1016/j.ctrsc.2015.02.001     Document Type: Article

References (5)

1. Committee For Medicinal Products For Human Use (CHMP) Guideline on procedure for the granting of a marketing authorisation under exceptional circumstances, pursuant to article 14 (8) of regulation (EC) No 726/2004 London 15 December 2005. EMEA/357981/2005 http://www.ema.europa.eu/docs/en-GB/document-library/Regulatory-and-procedural-guideline/2009/10/WC500004883.pdf
2. European Medicines Agency Post-authorisation safety studies (PASS) and post-authorisation efficacy studies http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document-listing/document-listing-000377.jsp&mid=WC0b01ac058066e979
3. European Medicines Agency Plan for implementation of the pharmacovigilance legislation by the European Medicines Agency 2 February 2012 EMA/64750/2012 http://www.ema.europa.eu/docs/en-GB/document-library/Other/2012/02/WC500121837.pdf
4. European Medicines Agency Pilot project on adaptive licensing 19 March 2014 EMA/254350/2012 http://www.ema.europa.eu/docs/en-GB/document-library/Other/2014/03/WC500163409.pdf
5. H.G. Eichler Adaptive licensing: taking the next step in the evolution of drug approval Clin Pharmacol Ther 91 3 2012 426 437