Draft guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products - Revision 1

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Document details

Download document Draft guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products - Revision 1
Reference number EMEA/149995/2008 Rev. 1
Status draft: consultation open
First published 2018-02-01
Last updated 2018-02-01
Consultation start date 2018-02-01
Consultation end date 2018-04-30
Email address for submissions atmpguideline@ema.europa.eu

Summary

This guideline replaces the guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products (EMEA/149995/2008)