The competent authorities for clinical gene therapy trials in Ireland are the Environmental protection agency (EPA), the Irish Medicines Board (IMB) and the Ethics committees of the hospitals involved. Applicants are to submit a dossier to each of the competent authorities. This can be done simultaneously. 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 (see also Guidance on the investigational medicinal product dossier). The IMB regulates clinical trials, as well as monitoring and inspecting products on the market to ensure their safety and efficacy. At EPA the decision is taken after consultations with other departments and experts. Several guidance documents by EPA are available and specifically mention clinical trials as an example of a deliberate release application (what those intending to use genetically modified organisms should know). A document is also available with examples of how GMO risk assessments should be conducted.

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