The European Medicines Agency released a reflection
paper on the classification of advanced-therapy medicines for public consultation yesterday.
The paper clarifies the legal basis for the classification of medicines as
advanced therapies and provides information on how these medicines are
classified as gene therapy, somatic-cell therapy, tissue-engineered or combined
medicines.
It also gives details on the types of information that applicants need to
submit to the Agency when applying for classification of their medicine as an
advanced therapy, and discusses of some borderline cases and areas where
scientific knowledge is limited or evolving rapidly.
Advanced therapies are medicines that are made from genes and cells and may
offer groundbreaking new treatment opportunities for many diseases and injuries.
As part of its role, the Agency's Committee for Advanced
Therapies (CAT) issues opinions on whether a medicine can
be classified as an advanced therapy, and can therefore be assessed for a
European-wide marketing authorisation via the European Medicines Agency.
The reflection paper is open for comments until 31 July 2012. Comments
should be sent to advancedtherapies@ema.europa.eu.