Is the European Medical Products Authorisation Regulation Equipped to Cope with the Challenges of Nanomedicines
Medical Products
Bibliographic Data
| ID | 7907331 |
|---|---|
| Authors | Bärbel R Dorbeck-Jung, Nupur Chowdhury (0000-0002-6747-0977, University of Twente) |
| Year | 2011 |
| Volume | 33 |
| Issue | 2 |
| Pages | 276-303 |
| Publication date | 2011-04-01 |
| Peer Reviewed | Yes |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | Law & Policy (JOURNAL) |
| Journal identifiers | ISSN: 0265-8240 • E-ISSN: 1467-9930 |
| Publisher | Wiley (PUBLISHER • GB) |
| DOI | 10.1111/j.1467-9930.2011.00339.x |
| OpenAlex | W2096842220 |
| Language | EN |
| References cited | 33 |
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
Constructivism and International Relations
From the Social Construction of Reality
What can Prudent Public Regulators Learn from the United Kingdom Government’s Nanotechnological Regulatory Activities
Regulatory Failures and Regulatory Solutions
Private Regulation of the Public Sector
A constructivist approach to understanding the European Union as a federal polity
Non-state actors and false dichotomies
The constitution of society
Alternatives to “Legalization
EU Regulation of Medical Devices and Pharmaceuticals in Comparative Perspective
| Citation velocity | historical |
|---|---|
| Highly cited | No |