EMA releases updated guidance on good clinical practice for consultation

The European Medicines Agency (EMA) has released an addendum to the International Conference on Harmonisation 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. The current ICH E6 guideline provides a unified standard on GCP. Developments in technology and risk management processes offer new opportunities to increase their efficiency by allowing sponsors to focus on relevant activities and the guidelines under consultation have been amended with this in mind. If you would like more information on how the updated provisions in the guidelines under consultation may affect you, please contact us on enquiries@wainwrightassociates.co.uk or call +44 (0)1628 530554.

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