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

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Current effective version

Adopted guideline

Currently under revision - see below

Reference numberEMEA/149995/2008
Published20/11/2008
Effective from31/12/2008
Keywords

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

 

DescriptionThe 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.


Document history

Revision 1

In progess

Draft guideline


 

Published: 01/02/2018

Deadline for comments: 30/04/2018

 

First version

Current version

Adopted guidelineIn operation: 31/12/2008–present

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