Is the European Medical Products Authorisation Regulation Equipped to Cope with the Challenges of Nanomedicines

This article analyses the emerging European regulatory activities in relation to nanopharmaceuticals. The central question is whether the regulatory responses are appropriate to cope with the regulatory problems nanomedicinal development is posing. The article explores whether the medical product regulations are robust enough, whether there are certain regulatory gaps, and whether the competent bodies have the expertise to evaluate nanomedicinal products when approval is applied for. Based on a social-constructive approach, the article identifies significant regulatory actors, their ideas on regulatory problems, and preliminary governance responses to them. It finds that the current dynamic regulatory structure appears robust enough to adapt to some of the technological challenges posed by nanomedicines. It concludes that regulators have not yet responded adequately to regulatory gaps related to definitions, classification and specific safety, quality, and efficacy standards that nanopharmaceutical development seems to require. As a consequence of these deficiencies legal certainty, a principle of high priority in European medical regulation policy, cannot be sufficiently provided

Authorization · Business · Certainty · Computer security · Constructive · Corporate governance · Economics · Law and economics · Political science · Quality (philosophy · Regulatory science · Risk analysis (engineering · Biomedical Ethics and Regulation · Computer Science · Medicine · Nanoparticles: synthesis and applications · Finance

• Stockholders and Stakeholders

  Open Access•Ralph E Freeman, David L Reed•California Management Review•1983

  Incluir item

• Constructivism and International Relations

  Emanuel Adler•Handbook of International Relations•2002

  Incluir item

• From the Social Construction of Reality

  P Berger, Peter L Berger et al.•The New Economic Sociology•2021

  Incluir item

• What can Prudent Public Regulators Learn from the United Kingdom Government’s Nanotechnological Regulatory Activities

  Open Access•Bärbel R Dorbeck-Jung•NanoEthics•2007

  Incluir item

• Regulatory Failures and Regulatory Solutions

  Open Access•Francis Haines•Law & Social Inquiry•2009

  Incluir item

• Private Regulation of the Public Sector

  Open Access•Colin Scott•Journal of Law and Society•2002

  Incluir item

• A constructivist approach to understanding the European Union as a federal polity

  Rey Koslowski•Journal of European Public Policy•1999

  Incluir item

• Non-state actors and false dichotomies

  Maria Green Cowles, Maria Cowles•Journal of European Public Policy•2003

  Incluir item

• The constitution of society

  Anthony Giddens•The constitution of society•1984

  Incluir item

• Alternatives to “Legalization

  Open Access•Martha Finnemore, Stephen J Toope•International Organization•2001

  Incluir item

• EU Regulation of Medical Devices and Pharmaceuticals in Comparative Perspective

  Open Access•Christa Altenstetter, Govin Permanand•Review of Policy Research•2007

  Incluir item