| Regulation (EC) No 1394/2007 aims to
standardise the regulation of advanced
therapy medicinal products (ATMPs) by
providing a working definition for ATMPs
and introducing special rules to control
such products. Until now, ATMPs have
largely fallen through the cracks of the
existing medicine and medical device
regimes in Europe, resulting in uncertainty
for the companies involved in researching
and developing these products as to the
correct regulatory regime for their
products, as well as raising broader public
concerns regarding the ethics, safety
and validity of these products in their
designated treatments.
The Regulation
aims to address these concerns and
provide a clear regulatory pathway for
ATMPs, and will apply throughout the EU
from 30th December 2008. However, any
products falling within the definition of an
ATMP under the Regulation which were
legally on the market on 30th December
2008 have until 30th December 2009
to comply with the requirements of
the Regulation.
ADVANCED THERAPY MEDICINAL
PRODUCTS DEFINED
Under the Regulation, the concept of an
ATMP is broadly defined in order to
capture three specific categories of
advanced therapies – tissue engineered
products, gene therapy medicinal products
and somatic cell therapy medicinal
products – with ATMPs described as any
medicinal product for human use falling
within one of these categories. |
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