The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations-Reference-Cited by-同舟云学术

The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations

Published:2018-03-05 Issue:5 Volume:84 Page:1013-1019
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

Tafuri Giovanni¹^ORCID,Lucas Inês²,Estevão Steve³,Moseley Jane²,d'Andon Anne⁴,Bruehl Hannah⁵,Gajraj Elangovan⁶,Garcia Sonia⁷,Hedberg Niklas⁸,Massari Marco¹,Molina Andrea⁹,Obach Mercè⁹,Osipenko Leeza⁶,Petavy Frank²,Petschulies Marco⁵,Pontes Caridad⁹,Russo Pierluigi¹,Schiel Anja¹⁰,Van de Casteele Marc¹¹,Zebedin-Brandl Eva-Maria¹²,Rasi Guido²,Vamvakas Spiros²

Affiliation:

1. Italian Medicines Agency (AIFA); Via del Tritone 181-00187 Rome Italy

2. European Medicines Agency (EMA); 30 Churchill Place London E14 5EU United Kingdom

3. The National Health Care Institute (ZIN); 4 Eekholt Diemen 1112 XH The Netherlands

4. Haute Autorité de Santé (HAS); 5 Avenue du Stade de France 93210 Saint-Denis France

5. The Federal Joint Committee (G-BA); Wegelystr. 8 D-10623 Berlin Germany

6. The National Institute for Health and Care Excellence (NICE); 10 Spring Gardens London SW1A 2BU United Kingdom

7. Spanish Agency of Medicines and Medical Devices (AEMPS); Calle Campezo 1, Edificio 8 28022 Madrid Spain

8. Dental and Pharmaceutical Benefits Agency (TLV); Fleminggatan 18 104 22 Stockholm Sweden

9. Servei Català de la Salut (CatSalut); Travessera de les Corts, 131-159, Edifici Olímpia 08028 Barcelona Spain

10. Norwegian Medicines Agency (NoMA); Strømsveien 96 0663 Oslo Norway

11. National Institute for Health and Disability Insurance (INAMI-RIZIV); Avenue de Tervueren 211 1150 Bruxelles Belgium

12. Main Association of Austrian Social Security Institutions (HVB); Kundmanngasse 21 A-1031 Vienna Austria

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/bcp.13524/fullpdf

Reference9 articles.

1. Scientific advice and protocol assistance http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000049.jsp&mid=WC0b01ac05800229b9

2. How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice;Tafuri;Br J Clin Pharmacol,2016

3. Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency;Regnstrom;Eur J Clin Pharmacol,2010

4. Regulatory watch: impact of scientific advice from the European Medicines Agency;Hofer;Nat Rev Drug Discov,2015

5. Health economics and outcomes research within drug development: challenges and opportunities for reimbursement and market access within biopharma research;Ref van Nooten;Drug Discov Today,2012

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