In May 2008 the European Medicines Agency (EMEA) published the draft of the
Guideline on Safety and Efficacy Follow-Up-Risk Management of Advanced Therapy
Medicinal Products (ATMP). It is for public consultation until the deadline on
15 August 2008.
Over the last few years, biotechnology was influenced by a rapid succession of
new discoveries both at the cellular as well as the molecular level. Based on
this new-found knowledge, the areas of tissue and cell therapy also made great
advances. The regulatory authorities reacted to these challenges with altered
directives for these areas, both for the classic fields of cell and tissue
harvesting as well as for the recently developed Advanced Therapy Medicinal
Products (ATMP), such as somatic cell therapy, gene therapy and tissue
Article 14 of the Guideline 1394/2007 requests the EMEA to draw up a detailed
guideline to the post authorisation follow-up system of efficacy and adverse
reactions and risk management.
The draft describes specific aspects of pharmacovigilance, risk management
planning, safety and efficacy follow-up of authorised ATMPs. Furthermore it will
characterise some aspects of clinical Follow-up of patients treated with ATMPs.
The main focus of this guideline is not the follow-up of subjects in
interventional clinical trials. The guideline considers that many subjects of
such clinical trials will require a very long or life-long follow-up. Because of
this it is necessary to take into account any existing requirements and
guidelines for follow-up of subjects in clinical trials, as well as the
follow-up system that was in place for subjects of clinical trials with the
The guideline concerns an area with fast growing knowledge and practical
experience. So it is expected that the Guideline will be frequently updated.
The target audience includes in particular marketing authorisation holders,
competent authorities for medicinal products and healthcare providers.
More details about the draft:
Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)