Draft Guideline on Safety and Efficacy Follow-Up-Risk Management of Advanced Therapy Medicinal Products

GMP News
2 July 2008
 

Draft Guideline on Safety and Efficacy Follow-Up-Risk Management of Advanced Therapy Medicinal Products


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 engineering.

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 particular ATMP.

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:
http://www.emea.europa.eu/pdfs/human/advancedtherapies/14999508en.pdf

Author:
Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)
 

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