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 currently governed by the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004, SI No 190 of 2004 - http://www.irishstatutebook.ie/eli/2004/si/190/made/en
The Regulations transposed into Irish law the provisions of Council Directive 2001/20/EC
A new Clinical Trials Regulation (EU) No 536/2014 was adopted on 16 April 2014, and implementation is planned to take place in 2019. When implemented, Directive 2001/20/EC and associated laws will be repealed.
The key features of the new Regulation are
- Identical rules for conducting clinical trials throughout the EU.
- Increase in the efficiency in approval process for clinical trials.
- Single submission & approval of multinational clinical trial applications through an EU ‘Clinical Trial portal and database’.
- A harmonised procedure for assessment by member states, divided in two parts:
- Strictly defined deadlines for assessment.
- Involvement of the ethics committees in the assessment procedure
The HPRA is working with the European Commission, the European Medicines Agency, the Heads of Medicines Agencies Clinical Trials Facilitation Group, the Department of Health, the Health Information and Quality Authority, Ethics Committees and the Irish Pharmaceutical Healthcare Association to prepare for the implementation of this Regulation.
More information is available on the European Commission and European Medicines Agency’s websites.
HPRA Pilot Project
The HPRA has initiated a national Pilot Project, in conjunction with the ethics committees, to prepare for implementation of the Clinical Trials Regulation in Ireland. The project will run until the implementation of the Regulation.
Sponsors are invited to participate. The main advantages for the sponsor are that they submit the HPRA and ethics committee documents to one location, the HPRA, and if feasible will receive a single national decision on the clinical trial.
The guide explains the process in detail. This guide will be updated, as necessary, throughout the period of the pilot project.
Documents must be submitted in a Part I and II dossier structure, as required by the legislation. Dossier structure folders are available (LINK), and clinical trial documents can be added to the folders under the relevant headings.
Part I dossier structure
Part II dossier structure
Substantial Modification dossier structure
For further information, please contact firstname.lastname@example.org