Use of the conditional marketing authorization pathway for oncology medicines in Europe-Reference-Cited by-同舟云学术

Use of the conditional marketing authorization pathway for oncology medicines in Europe

Published:2015-07-17 Issue:5 Volume:98 Page:534-541
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Hoekman J¹²,Boon WPC¹²,Bouvy JC¹,Ebbers HC¹,de Jong JP³,De Bruin ML¹

Affiliation:

1. Utrecht Institute for Pharmaceutical Sciences; Utrecht University; Utrecht The Netherlands

2. Innovation Studies Group; Faculty of Geosciences; Utrecht University; Utrecht The Netherlands

3. Exon Consultancy; Amsterdam The Netherlands

Funder

European Federation of Pharmaceutical Industry & Associations (EFPIA)

The Association of the European Self-Medication Industry (AESGP)

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/cpt.174/fullpdf

Reference25 articles.

1. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma;Eichler;Nat. Rev. Drug Discov.,2008

2. Accelerated access to innovative medicines for patients in need;Baird;Clin. Pharmacol. Ther.,2014

3. The risks of risk aversion in drug regulation;Eichler;Nat. Rev. Drug Discov.,2013

4. Diagnosing the decline in pharmaceutical R&D efficiency;Scannell;Nat. Rev. Drug Discov.,2012

5. European Medicines Agency Guideline on the scientific application and the practical arrangements necessary to implement Commission Regulation (EC) No. 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of regulation (EC) No 726/2004. Doc. Ref. EMEA/509951/2006 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004908.pdf 2006

Cited by 50 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. What could health technology assessment learn from living clinical practice guidelines?;Frontiers in Pharmacology;2023-08-24

2. Perspectives on how to build bridges between regulation, health technology assessment and clinical guideline development: a qualitative focus group study with European experts;BMJ Open;2023-08

3. Reimbursement Coverage Decision Making for Digital Health Technologies in South Korea: Does It Fit the Value Framework Used in Traditional Medical Technologies?;Value in Health Regional Issues;2023-07

4. Comparison of novel oncology drugs that received dual approval from the US accelerated approval and EU conditional marketing authorisation pathways, 2006–2021: a cross-sectional study;BMJ Open;2023-06

5. European Conditional Marketing Authorization in a Rapidly Evolving Treatment Landscape: A Comprehensive Study of Anticancer Medicinal Products in 2006–2020;Clinical Pharmacology & Therapeutics;2023-05-02