ABSTRACT

The Clinical Trial Regulation EU No 536/2014 was developed in order to synchronize the evaluation and oversight procedures for clinical trials on medications intended for human use. This document provides further explanation of the concepts set forth in Directive 2001/20/EC and the Voluntary Harmonization Procedure (VHP) by the Heads of Medicines (HMA) Clinical Trials Facilitation Group (CTFG). Once implemented, it will encourage: Standardizing the CT application procedure will increase efficiency throughout Europe. Greater transparency of data and processes in the medical industry increased medication effectiveness and safety The rule aims to offer a single, consistent gateway and database to regulatory organizations and trial sponsors in each member state. The portal will act as the main method for sponsors to submit notices and applications while also allowing authorities to monitor the trial and make assessments. The new regulation has had a significant impact on the following things: • Streamlining the clinical trial application procedure for the entire EUprotocols to assess and approve clinical trials, avoid duplication, and speed up the process Introducing the concept of a single decision on a clinical trial, • Streamlining reporting procedures to save researchers from delivering nearly identical data on the conduct of the study to different bodies The European Medicines Agency (EMA) provided their broad perspective in March 2017. On the transition from the directive to the rule and the road to the portal and database's implementation Keywords: CTIS, EMA, MSc, RMS.
Publication date: 01/09/2025

https://ijbpas.com/pdf/2025/September/MS_IJBPAS_2025_9343.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.9.9343