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Pharmaceuticals

Published online by Cambridge University Press:  20 January 2017

Alessandro Spina
Alessandro Spina*
Affiliation:
European Medicines Agency, London
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Abstract

This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.

Type
Reports
Information
European Journal of Risk Regulation , Volume 1 , Issue 1 , March 2010 , pp. 81 - 82
Copyright
Copyright © Cambridge University Press 2010

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References

1 Bernstein, M., Regulating Business by Independent Commissions (Westport Conn.: Greenwood Press 1977)Google Scholar.

2 This has resulted also in the first dispute, still pending before the General Court, directed only against an administrative act of the Agency, Nycomed Danmark v. European Medicines Agency, T-52/09.

3 Sabel, C./Zeitlin, J., Experimentalist Governance in the European Union – Towards a new architecture (Oxford University Press 2010)Google Scholar.

4 Available at the Internet on http://www.ema.europa.eu.

5 The possibility of legal review of acts of the Agency should be also put in the context of a doctrinal position that favours the possibility of directly challenging the scientific opinions of the European Medicines Agency, notwithstanding the fact that they are merely preparatory acts, arguing on the basis of the Les Verts principle, cf. Chiti, E., An important part of EU's institutional machinery: features, problems and perspectives of European agencies, in Common Market Law Review (2009), p. 1420.

6 A press release of Mr. Dalli's hearing is available at the web site of the Parliament http://www.europarl.europa.eu/news/expert/infopress_page/008-67215-013-01-03-901-20100113IPR67206-13-01-2010-2010-false/default_en.htm.

7 Reference is made here in particular to the Scientific Committee on Consumer Safety (SCCS), the Scientific Committee on Health and Environment Risks (SCHER) and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and the Pool of Scientific Advisors on Risk Assessment established by European Commission Decision 2008/721.

8 The European Food Safety Authority (EFSA) in Parma and the European Centre for Disease Prevention and Control (ECDC) in Stockholm.