Health Products Regulatory Authority (HPRA)2022-02-012022-02-012022-01-31http://hdl.handle.net/10147/631264Clinical trials contribute significantly to advances in medical treatment. They may be conducted for a range of purposes, for example to test whether a new treatment or combination of treatments is safe and effective, or to explore new ways to use existing medicines. A new EU Clinical Trial Regulation (Regulation No 536/2014, hereafter ‘CTR’), was adopted on 16 April 2014, and became applicable on 31 January 2022. The CTR is designed to benefit patients and medical research in Europe by streamlining the approval of clinical trials across the Member States. Key features of the new CTR include: - Single submission and approval of mononational and multinational clinical trial applications through an EU clinical trial portal and database known as the Clinical Trial Information System (CTIS), hosted by the European Medicines Agency (EMA) - A single fee per Member State - Identical rules for conducting clinical trials throughout the European Union (EU) - Strictly defined timelines for assessment - Increased efficiency of the approval process for clinical trials These features will assist the CTR in achieving its aim of creating a favourable environment for conducting trials in the EU while also ensuring that the highest standards of safety for participants are maintained. In addition to the application of the CTR, the European Commission (EC), the EMA, and the Heads of Medicines Agencies (HMA) have launched Accelerating Clinical Trials in the EU (ACT EU). This initiative seeks to transform how clinical trials are conducted, promote the development of high-quality, safe and effective medicines, and to better integrate clinical research in the European health system. The HPRA will be actively involved in this initiative through its participation in EMA and HMA. In this guide we describe the conduct of clinical trials under the CTR in Ireland. It should be read in conjunction with EU and national legislation, and EC and EMA guidelines. A list of relevant documents is provided in the References section of this guide.enREGULATIONCLINICAL TRIALSRESEARCHGuideline