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HPRA Guide to Clinical Trials Conducted under the Clinical Trials Regulation (CTR) in Ireland

The Health Products Regulatory Authority published a guideline and is seeking feedback on its approach to an aspect of Clinical Trial Regulation (CTR) that allows certain preparation, relabeling, and repackaging steps to be performed at facilities without a manufacturer's authorization.

Clinical trials significantly contribute to advances in medical treatment and may be conducted for a variety 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.

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:

  1. Single submission and approval of mono national 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)

  2. A single fee per Member State

  3. Identical rules for conducting clinical trials throughout the European Union (EU)

  4. Strictly defined timelines for assessment

  5. Increased efficiency of the approval process for clinical trials

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 into the European health system. The HPRA will be actively involved in this initiative through its participation in EMA and HMA.

Click on this LINK to see Clinical Trials Conducted under the Clinical Trials Regulation (CTR) in Ireland.


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