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Gene Therapy Clinical Trials Regulatory Affairs

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. This site is an attempt to give an overview 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.

Quick links to major regulatory institutes:

Recombinant DNA Advisory Committee (RAC)
Center for Biologics Evaluation and Research (FDA - CBER)
European Union - Biotechnology (EU)
The European Medicines Agency (EMA)
Gene Therapy Discussion Group of The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)