Advanced Therapy Medicinal Products (ATMPs)

The term refers to a category of innovative medicines for human use that are based on cells, genes, or tissues. ATMPs include the following three main categories:

1. Gene therapy medicinal products: These involve inserting, altering, or removing genetic material usually within a patient's cells to treat, prevent or diagnose diseases. For example, replacing a faulty gene responsible for a genetic disorder.
2. Somatic cell therapy medicinal products: These involve the administration of cells or tissues where the biological characteristics have been altered to treat, prevent or diagnose diseases. These cells might be for example stem cells, immune cells, or other types of cells which can repair or replace damaged tissue.
3. Tissue engineered products: These entail creating or regenerating functional products using a combination of cells and/or tissue and cellular products, bio-molecules, bio-materials, chemical substances, scaffolds or matrices for the purpose of regeneration, repair or replacement of human tissue.

ATMPs represent a promising frontier in medicine, offering new treatments for conditions that were previously difficult or even impossible to address. These products have the potential to be highly personalized, as they often involve using a patient’s own cells, reducing the risk of immune rejection. However, their development and manufacturing are complex, requiring advanced technology and specialized regulatory oversight to ensure safety and efficacy.

For more details you might want to refer to Regulation (EC) No 1394/2007.