- Currently, the conduct of clinical trials in the EU is regulated by the Clinical Trials Directive (Directive 2001/20/EC) which sets out the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. The Clinical Trials Directive has been enacted into Irish law by S.I No. 374 of 2006*. On 16th April 2014, the European Commission adopted the new Regulation No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (the Clinical Trials Regulation). The Clinical Trials Regulation will replace the legislation currently in force in Ireland.
Aim of the new Clinical Trials Regulation
- The Clinical Trials Regulation is intended to "cut red tape" thereby making it easier for pharmaceutical companies to conduct multinational clinical trials, ultimately increasing the number of trials conducted within the EU.
- The primary goals of the Clinical Trials Regulation are to:
- Streamline the approval process for studies conducted across multiple EU Member States;
- Harmonise the regulation of clinical trials throughout EU Member States; and
- Increase the transparency of clinical trial results.
Entry into Force
- The Clinical Trials Regulation was published in the EU Official Journal on 27th May 2014. It entered into force on 16th June 2014, 20 days after publication. However, it will only become applicable on 28th May 2016 at the earliest. The exact date upon which the Clinical Trials Regulation will become applicable will depend on the completion of the necessary I.T. solutions required to provide for the new EU Portal for the Central Submission of Data in relation to clinical trials. The European Medicines Agency (EMA) will also set up and maintain an electronic database for reporting in respect of clinical trials, which will be known as the EudraVigilance Database. Once the EU Portal and EMA Database have achieved full functionality, the European Commission will publish a notice in the EU Official Journal acknowledging this fact and providing notification that the Clinical Trials Regulation will become applicable 6 months after the date of this publication.
Streamlining the Approval Process
- The Clinical Trials Regulation streamlines the review and
approval process by permitting sponsors to submit only one
application using the EU Portal, which will then undergo a
- Assessment of the clinical trial with respect to those aspects which have been harmonised, as well as a review of the application by all Member States in which the study will be conducted;
- Assessment of the aspects of the clinical trial that are "intrinsically national in nature". This second step is performed by each EU Member State separately and includes a review and assessment by the Ethics Committee (a committee which is expected to have an input on the conduct of clinical trials) in each Member State. There are 13 Ethics Committees in Ireland.
- Industry should thoroughly consider the impact which the new Clinical Trials Regulation will have and begin putting in place all relevant measures to ensure compliance with its provisions.
*S.I 374 of 2006 European Communities (Clinical Trials on medicinal products for human use) (Amendment No.2) Regulations 2006.
This article contains a general summary of developments and is not a complete or definitive statement of the law. Specific legal advice should be obtained where appropriate.