Risk management

Article 14 (4) of Regulation (EC) No 1394/2007 on advanced therapy medicinal products requires the European Medicines Agency to draw up detailed guidelines relating to the post authorisation follow-up of efficacy and adverse reactions, and risk management. As a result a guideline has been adopted and published by the Agency, its scientific committees and working parties.

Questions relating specifically to the authorisation of advanced therapy medicinal products may be submitted to:
AdvancedTherapies @ema.europa.eu

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

Adopted Reference Number: EMEA/149995/2008 Legal effective date: 01/01/2009

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

Draft: consultation closed Reference Number: EMEA/149995/2008

Overview of comments received on draft guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products

Reference Number: EMEA/477055/2008