FDA Adopts ICH Good Clinical Practice Addendum

by TLM


The US Food and Drug Administration (FDA) on Wednesday finalized its version of the addendum to the International Council for Harmonisation’s (ICH) good clinical practice (GCP) guideline.

The addendum, referred to as E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1), updates the previous version of the E6 guideline from 1996 and was adopted by the ICH Assembly in November 2016.

According to FDA, the guideline was amended “to encourage implantation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting, and also updates standards regarding electronic records and essential documents.”

FDA also says the updated standard will “improve clinical trial quality and efficiency, while maintaining human subject protection and reliability of trial results.”

Shortly after its adoption by ICH, the European Medicines Agency (EMA) finalized their version of the guideline, which came into effect for the EU in June 2017. Switzerland has also amended its Clinical Trials Ordinance (ClinO) to refer to E6(R2) as of 1 May 2017.

Additionally, Health Canada announced last May that it plans to fully implement the addendum in April 2018, though Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has not yet said when it will implement the new guideline.

FDA, Federal Register Notice


Mehzer, Michael. Https://Www.raps.org/News-and-Articles/News-Articles/2018/2/Fda-Adopts-Ich-Good-Clinical-Practice-Addendum.