EMA draft revision: Guideline on safety and efficacy follow-up and risk management of Advanced Therapy Medicinal Products (EMEA/149995/2008 rev.1)

As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2018 about EMA draft revision: Guideline on safety and efficacy follow-up and risk management of Advanced Therapy Medicinal Products (EMEA/149995/2008 rev.1) can be found below.

EMA draft revision: Guideline on safety and efficacy follow-up and risk management of Advanced Therapy Medicinal Products (EMEA/149995/2008 rev.1)

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