Advanced therapy medicinal products

Advanced therapy medicinal products (ATMPs) are medicinal products for human use that are based on genes, tissues or cells. They offer ground-breaking new possibilities for the treatment of diseases and injuries.

ATMPs can be categorised into three main types:

  • Gene therapy medicines: these contain genes that lead to a therapeutic, prophylactic or diagnostic effect. They work by introducing "recombinant" genes into the body, usually to treat a range of diseases, including genetic disorders, cancer or long-term illnesses. A recombinant gene is a section of DNA that is produced in the laboratory by bringing together DNA from different sources.
  • Somatic-cell therapeutics: They contain cells or tissues that have been manipulated to change their biological properties, or cells or tissues that are not intended to perform the same essential functions in the body. They can be used to cure, diagnose or prevent diseases.
  • Tissue-engineered medicinal products: These contain cells or tissues that have been modified so that they can be used to repair, regenerate or replace human tissue.

In addition, some ATMPs may contain one or more medical devices as an integral part of the medicinal product, which are then referred to as combined ATMPs. An example of this is cells embedded in a biodegradable matrix or scaffold.

Reference:https://www.ema.europa.eu/en/human-regulatory-overview/advanced-therapy-medicinal-products-overview

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