Application of EU Clinical Trial Regulation Delayed to 2019
By Zachary Brennan -
Published 16 June 2017
The European Medicines Agency’s management board said that due to technical difficulties with the development of IT systems, the application of the clinical trial regulation has to be postponed.
Categories: News, Europe, EC, EMA, Clinical, Compliance, Government affairs
Tags: EMA clinical trial regulation, clinical trial regs, EMA portal
Impact of the Revised EU Clinical Trial Regulation
By Siegfried Schmitt, Federico Bonacci, MD, Daniela Lisini, PhD, Dr. Viviana Mascilongo -
Published 24 April 2017
Clinical Trial Regulation EU No 536/2014 will come into effect in 2018. This article reports on aspects of the revised regulation and evaluates its potential impact on clinical trials conducted to assess medicinal products for human use. It discusses changes impacting the critical role of the Ethics Committees in the approval process for clinical trials as well as the planned, centralized data reporting channel, referred to as "the portal." While revisions to the regulation are still underway, readers will benefit from the assessment of its current status and anticipated developments.
Categories: Features, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs
Tags: Clinical Trial Regulation, EU No 536/2014