EMA Issues Addendum for Good Clinical Practice

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 08-24-2015 14:23


The European Medicines Agency has released an addendum to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 (R2) guideline on good clinical practice (GCP) for a six-month public consultation. Stakeholders may send their comments by February 3, 2016.

GCP is an international ethical and scientific quality standard for designing, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected and that clinical-trial data are credible.

The current ICH E6 guideline provides a unified standard on GCP. It describes responsibilities and activities of sponsors, monitors, investigators, and ethics committees. Since the finalization of this guideline in 1996, the scale, complexity, and costs of clinical trials have increased, which include developments in technology and risk management processes. With this in mind, the guideline has been amended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting while continuing to ensure the protection of clinical trial participants and data integrity as well as to update standards regarding electronic records and essential documents intended to increase the quality and efficacy of clinical trials.

Source: European Medicines Agency


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