We well know that the origin of what we could call a revolution of the celi therapy sector began with the entry into farce of the famous legislative decree 1394/2007, which regulated, classified and assimilated medicinal products for human use of cellular origin to sterile drugs and, therefore, regulated their production using the same rules adopted for the latter. Prior to this decree, cell-based products were not considered medicinaI products.
Despite a complex environment many products evolved anyway. Some of them along different and often complementary paths, and some of these products have gained the possibility of being transplanted, in the context of clinicaI studies, into compassionate therapies and even as products placed on the market, authorized to be traded throughout the European Union by the European Medicine Agency (EMA).

What did decree 1394/2007 establish (and stilI establishes)?

Basically, for our purpose we should keep in mind three fundamental aspects (the decree deals with the whole route of the drug, from the authorization to production to packaging, from Clinical Trials to Pharmacovigilance and so on):

• It classifies, categorizes and establishes that cell-based products (i.e. where transplanted cells are "the cure") must be considered sterile drugs and therefore must be manufactured in accordance with the GMP reported in
  the sterile drug legislation (Annex 1 to the EU Guidelines, Vol 4), supplementing the provisions of directive 2001/83/EC, Part IV, Annex I.
• It required anyone who intended to deaI with the development of cellular products to comply with the
  legislation by producing such drugs in specific environments and according to a specific discipline, regulated by current legislation.
• It established the CAT (Committees far Advanced Therapies) at the EMA, entrusted with the preliminary evaluation of applications for the development and production of ATMP drugs.

The result was that many products, quite promising a few years ago, in order to achieve a regular clinical use suffered a slowdown necessary for the adaptation of the structures and only in more recent times, clearly just a few years ago, they started to regain (or gain for the first time) the status of products in possession of the MA (Market Authorization) issued by the EMA.

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