Hidalgo-Simon, A. (2021, December 13). Regulation of ATMPs in Europe: present and future [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved March 4, 2024, from https://hstalks.com/bs/4827/.
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Published on December 13, 2021
Dr. Ana Hidalgo-Simon has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
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Hello, my name is Ana Hidalgo-Simon,and I work for the European Medicines Agency (EMA).In this talk today,I'm going to be talking about the regulation of ATMPs in Europe.The European Medicines Agency isthe coordination hub for the regulation of medicines in Europe.We do have more than one per country in Europe, that is national competence authorities,but for these complex therapies, we do the coordinationand all the regulatory life from the central hub which is the EMA.
I do not have any conflict of interest.
This talk is divided into two parts.In Part 1, I'm going to be describing what we understand about ATMPs,what they are, and how they are regulated.Also a description of the available tools for developers and users.In Part 2, I will be talking about the future, going over the challengesgoing over the challenges that we have at the momentand the potential bridges that we are putting in to address those challenges.
We move now onto Part 1.How do we classify and describe advanced therapies in Europe?
ATMPs are classified in Europe in three large brackets,but you will have to be a bit careful in assuming that these definitions will apply everywherebecause it doesn't at the moment.You will find that what is classified as gene therapy in Europe and in the FDA has a large overlap,but it's not exactly the same.The therapies in these three brackets:gene therapies, somatic cell therapies and tissue-engineered products,are all considered ATMPs and they are regulated as medicines in the EU.In contrast to that,you have transplants, transfusions,or the movement of cells that are non substantiallymanipulated into a homologous position in the body,and those are not regulated as medicines.