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 is
the 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 coordination
and 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 challenges
going over the challenges that we have at the moment
and 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 everywhere
because 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 substantially
manipulated into a homologous position in the body,
and those are not regulated as medicines.