On 4 August 2015, the Committee for Medicinal Products for Human Use (“CHMP”) launched a six month public consultation process on a draft addendum to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 (R2) Guideline for good clinical practice.
It is recalled that compliance with good clinical practice (“GCP”) must be observed by sponsors, investigators and other participants involved in the design, initiation, conduct, recording and reporting of clinical trials that involve the participation of human subjects. This requirement is provided in the Clinical Trials Directive and the GCP Directive.
The draft addendum to the Guideline for good clinical practice (ICH) E6 is intended to introduce the following changes:
1. To encourage the implementation of an improved and more efficient approach to clinical trials that involve the participation of human subjects; and
2. To update standards concerning electronic records and essential documents which are intended to increase the quality and efficacy of clinical trials.
Some of the modifications which are reflected in the integrated draft addendum include areas such as, monitoring, validation of computerized systems, recordkeeping, the quality management system and issues of non-compliance.
Once the draft addendum to the Guideline on good clinical practice (ICH) E6 is adopted in its final form it will replace the current Guideline on clinical practice (ICH) E6.
The consultation process will remain open until 3 February 2016. Comments may be submitted by interested companies and individuals using the template form indicated on the draft addendum to the Guideline for good clinical practice to ich@ema.europa.eu.