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http://ec.europa.eu/enterprise/pharmaceuticals/advtherapies/advanced_en.htm
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This page provides information on advanced therapies.
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eu, commission, enterprise, industry, industrial sector, pharmaceuticals, health care
industry, health, medicine, medicinal product, advanced therapies, gene therapy, cell
therapy, tissue engineering, nanomedicines, pharmacogenomics
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Advanced Therapies
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New technologies, therapies and medicines are emerging; this includes regenerative
medicine, more personalised treatments, as well as the development of
nanomedicines. The Commission is committed to monitoring scientific progress and
to constantly review Community legislation in the light of new developments so as to
make safe, novel treatments available to patients as early as possible.
Advanced therapy medicinal products are new medical products based on genes
(gene therapy), cells (cell therapy) and tissues (tissue engineering). These advanced
therapies herald revolutionary treatments of a number of diseases or injuries, such as
skin in burns victims, Alzheimer's, cancer or muscular dystrophy. They have huge
potential for patients and industry.
The lack of an EU-wide regulatory framework in the past led to divergent national
approaches which hindered patients’ access to products, hampered the growth of this
emerging industry and ultimately affected EU competitiveness in a key biotechnology
area.
The EU institutions agreed on a Regulation on advanced therapies (Regulation (EC)
1394/2007), designed to ensure the free movement of advanced therapy products
within Europe, to facilitate access to the EU market and to foster the competitiveness
of European companies in the field, while guaranteeing the highest level of health
protection for patients.
The main elements of the Regulation are:

A centralised marketing authorisation procedure, to benefit from the pooling
of expertise at European level and direct access to the EU market.

A new and multidisciplinary expert Committee (Committee for Advanced
Therapies), within the European Medicines Agency (EMEA), to assess
advanced therapy products and follow scientific developments in the field.

Technical requirements adapted to the particular characteristics of these
products.

Special incentives for small and medium-sized enterprises.
This new Regulation also marks the recognition that a number of advanced therapy
products actually combine biological materials, such as tissues or cells, and chemical
structures such as metal implants or polymer scaffolds. These combination products
lie at the border of the traditional pharmaceutical area and other fields (e.g. medical
devices). They therefore cannot be regulated as ‘conventional’ drugs and need
adapted requirements. In addition, it should be borne in mind that a significant share
of economic operators involved in this field are not large pharmaceutical companies,
but rather small and medium-sized enterprises or hospitals.
‘-Omics’ and Personalised Medicine
New genetic technologies such as pharmacogenomics enable scientists to use
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patients’ genetic information in order to better determine the right drug, at the right
dose and at the right time. With the emergence of such technologies, personalised
medicine is now on the horizon. This field is already affecting the business strategy of
pharmaceutical companies, the industry structure (with the creation of highly
innovative and specialised small and medium-sized enterprises), the design of clinical
trials and the way medicines are prescribed.
Although it is at the moment too early to tell whether pharmacogenomics and other ‘omics’ technologies will indeed revolutionise the way medicines are developed and
prescribed, it is important that the Commission closely monitor this trend towards
personalised treatments and reflect on how it can support its development, by
regulatory and non-regulatory means.
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Advanced Therapies - Major developments
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