ATMPs (Advanced Therapy Medicinal Products) encompass three breakthrough categories of treatments:

🧬 Gene therapy medicinal products
🧫 Somatic cell therapy medicinal products
🧩 Tissue-engineered products

To these three main categories, we may add combined ATMPs and hospital exemption ATMPs (custom-made, non-routine preparations).

These products target serious conditions — cancers, rare diseases, degenerative disorders — and for some patients, they represent the only available therapeutic hope.

First outlined as early as 2003, ATMPs were formally established in 2007 by Regulation (EC) No 1394/2007, which constitutes the official birth of an unprecedented regulatory category in European pharmaceutical law.
Designed as a framework for innovation, they embody both the pioneering ambition of the European Union and the contemporary tensions between safety, early access, and sustainability.