Before a medicinal product can be authorised for use, it must go through the clinical trials process to ensure that it is safe and effective and also that the quality of the product is sufficient.
The HPRA is responsible for the assessment of clinical trials with medicinal products conducted in Ireland. The types of trials assessed range from first-in-man studies for new compounds to studies with products which already have marketing authorisations.
Clinical trials begin with small studies in a controlled population of volunteers or patients and, as data are gathered, expand to large scale studies in patients. These large scale studies will often investigate the new product and the currently used treatment to see how these two compare. As information is obtained, larger numbers of patients are exposed to the new product and safety data can be collected showing the safety of the product in the intended patient population. Information on the quality of the product and its non-clinical safety will have been obtained before the clinical trial programme commences.
Clinical trials in Ireland are governed by the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004, SI No 190 of 2004. http://www.irishstatutebook.ie/2004/en/si/0190.html Clinical Trials Applications
The Regulations transposed into Irish law the provisions of Council Directive 2001/20/EC (http://www.eortc.be/Services/Doc/clinical-EU-directive-04-April-01.pdf). The regulations supersede the Control of Clinical Trials Acts 1987 – 1990 for clinical trials using medicinal products.
Good Clinical Practice (GCP) Inspections Reporting Serious Adverse Events
Annual Safety Reporting Requirements