Guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products - Scientific guideline

The guideline describes specific aspects of pharmacovigilance, risk management planning, safety and efficacy follow-up of authorised ATMPs, as well as some aspects of clinical follow-up of patients treated with such products.

Keywords: Guideline on safety and efficacy, follow-up - risk management of advanced therapy medicinal products (ATMPs)

Current effective version - Under revision - see below

Guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products

AdoptedLegal effective date: 01/01/2009Reference Number: EMEA/149995/2008

Document history - Revision 1 (in progress)

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

Consultation dates: 01/02/2018 to 01/05/2018Draft: consultation closedReference Number: EMEA/149995/2008 Rev. 1Summary:

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