The European Commission is launching an online targeted public consultation on the draft guidelines on good clinical practice for Advanced Therapy Medicinal Products (ATMPs) addressed particularly to small and medium-sized enterprises (SMEs), academia, hospitals and patient organisations.
The Commission has to draw up guidelines on good clinical practice specific to advanced therapy medicinal products. The document will focus on ATMP specificities only and will apply to the GCP Guidelines of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The comments are invited to be sent by 31 October 2018. Responses should preferably be sent to sante-pharmaceuticals-B5(at)ec.europa.eu.
Find more information here.
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