Biomedical research

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Politics

In this section you find regulatory issues surrounding gene therapy.


Regulatory and ethical issues of gene transfer are usually a secondary preoccupation of researchers. Conducting gene therapy clinical trials with genetically modified organisms as the vectors presents unique safety and infection control issues.

The area is governed by a range of legislation and guidelines, some unique to this field, as well as those pertinent to any area of clinical work. Gene therapy legislation aims at protecting the human subject, the general public and the environment. At Gene Therapy Net an overview can be found of the different regulations and guidelines in Europe (nearly all countries including European member states), United States of America and the rest of the world (Asia, Australia).
 

Quick links to major regulatory institutes:

In the USA: Center for Biologics Evaluation and Research (FDA - CBER)
In the UK: Gene Therapy Advisory Committee (GTAC)
In the EU: European Union - Biotechnology (EU) and The European Medicines Agency (EMEA)
 

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