The Drug Regulatory Affairs System in the Federal Republic of Germany

Schmitt-Rau, Karlheinz

doi:10.1002/j.1552-4604.1988.tb05715.x

Cited by 5 publications

(1 citation statement)

References 1 publication

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“…Many groups are active in supporting or criticizing proposals issuing from the EC Commission: national governments, individual manufacturers, groups of manufacturers, associations of professionals, and consumer groups (Griffin 1986;Bakke and Alonso 1988;Drost and Reijnders 1987;Schmitt-Rau 1988;Weintraub 1982Weintraub , 1985. Most urge changes and make counterproposals.…”

Section: Institutional Network For Community Proposalsmentioning

confidence: 99%

Pharmaceutical Regulation in the European Community: Barriers to Single Market Integration

Orzack¹,

Kaitin²,

Lasagna³

1992

Journal of Health Politics, Policy and Law

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The European Community (EC) plans to create a single market for pharmaceutical medicines, but the drug industry is closely linked to cultural and societal values concerning health; to the national regulatory agencies responsible for the evaluation of safety, quality, and efficacy of new drugs; to multinational and domestic companies competing in national and international markets; and to varied interest groups of professionals and consumers organized along national and multinational lines. We review the history of the EC's policy proposals, examine reactions from all these interested parties, and assess the prospects for integration into a single market. The contentious debate that continues among the parties over national prerogatives, industrial interests, professional mandates, and consumer concerns clouds the prospects for a system of centralized drug registration that will be acceptable to all EC member states.

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Section: Institutional Network For Community Proposalsmentioning

confidence: 99%

Pharmaceutical Regulation in the European Community: Barriers to Single Market Integration

Orzack¹,

Kaitin²,

Lasagna³

1992

Journal of Health Politics, Policy and Law

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The Regulatory Status of Radiopharmaceuticals in Europe

Schmitt-Rau

1990

The Journal of Clinical Pharma

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The creation of neo–liberal corporate bias in transnational medicines control: The Industrial shaping and interest dynamics of the European regulatory state

Lewis

Abraham

2001

European J Political Res

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Drawing on the political theories of corporatism, neo-liberalism and pluralism, and on comparative empirical research in Brussels, Germany, Sweden and the UK, this article conceptualises the nature of Europeanised medicines regulation. It argues that a marketisation of regulation has been established in the European Union as a result of competition between national regulatory agencies for 'regulatory business' from the pharmaceutical industry. In the pharmaceuticals sector the Europeanised regulatory state is a product of three key factors: (a) the European Commission's commitment to an 'efficiency' regime which would meet the political objectives of a single European market and the commercial agendas of transnational pharmaceutical companies, (b) the endemic corporate bias associated with medicines regulation in the most influential member states, and (c) the considerable success of neo-liberal politics across a number of major member states, including Germany, Sweden and the United Kingdom.

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The Drug Regulatory Affairs System in the Federal Republic of Germany

Cited by 5 publications

References 1 publication

Pharmaceutical Regulation in the European Community: Barriers to Single Market Integration

Pharmaceutical Regulation in the European Community: Barriers to Single Market Integration

The Regulatory Status of Radiopharmaceuticals in Europe

The creation of neo–liberal corporate bias in transnational medicines control: The Industrial shaping and interest dynamics of the European regulatory state

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