Gene Therapy Legislation in Ireland
At the IMB a Clinical Trials Sub-Committee meets to review all applications. This committee is a sub-committee of the Advisory Committee for Human Medicines. The role of the IMB is to assess applications from sponsors to conduct clinical trials with medicinal products. The IMB regulates clinical trials, as well as monitoring and inspecting products on the market to ensure their safety and efficacy.
The EPA is responsible for GMO related activities, in particular, the contained use and the deliberate release of GMOs into the environment. Heretofore, the EPA has regulated gene therapy clinical trials under Directive 2001/18/EC and the corresponding implementing Regulations, however, prospective applicants are advised to contact the EPA in advance of submitting an application such that the proposed activity may be subject to a case-by-case analysis.
In their review of an application, the EPA will consult with their Advisory Committee on GMOs as well as other responsible national Agencies. The GMO Advisory Committee was established under national legislation to advise the EPA on GMO related matters. In carrying out their function it is the role of the EPA to ensure that no harm will be caused to human health or to the environment.
Contact details, links to national Regulations implementing EU legislation and guidance may be found on the EPA website www.epa.ie. (http://www.epa.ie/licensing/gmo)
(Last reviewed by the Competent Authority: 27 April 2010)