Advanced therapy medicinal products: Overview
Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer groundbreaking new opportunities for the treatment of disease and injury.
ATMPs can be classified into three main types:
- gene therapy medicines: these contain genes that lead to a therapeutic, prophylactic or diagnostic effect. They work by inserting 'recombinant' genes into the body, usually to treat a variety of diseases, including genetic disorders, cancer or long-term diseases. A recombinant gene is a stretch of DNA that is created in the laboratory, bringing together DNA from different sources;
- somatic-cell therapy medicines: these contain cells or tissues that have been manipulated to change their biological characteristics or cells or tissues not intended to be used for the same essential functions in the body. They can be used to cure, diagnose or prevent diseases;
- tissue-engineered medicines: these contain cells or tissues that have been modified so 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 medicine, which are referred to as combined ATMPs. An example of this is cells embedded in a biodegradable matrix or scaffold.
For detailed definitions of the different groups of advanced therapy medicinal products, refer to Regulation (EC) No 1394/2007 and Directive 2001/83/EC.
In April 2020, EMA'sCommittee for Advanced Therapies (CAT) advised patients and the general public to beware of unproven cell-based therapies.
This followed the appearance of advertisements for cell therapies as cures for serious conditions across the European Union in early 2020.
In its statement, the CAT warned against the use of unregulated cell-based therapies, which may be ineffective and increase the risk of serious adverse reactions.
Healthcare providers should explain the benefits and risks of the cell-based therapies that they are providing to patients, as well as confirming that regulatory authorities have approved their use.
Anyone with doubts can contact EMA or their national competent authority.
The CAT’s statement replaces a statement it issued in 2010 following reports of unregulated stem-cell therapies being offered to patients.
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