What are advanced therapy medicinal products (ATMPs)?
Advanced therapy medicinal products are based on living materials such as cells, tissues or genes and constitute a separate class of medicines that are subject to their own regulatory framework.
Advanced therapy medicinal products (ATMPs) are biological medicines based on cells, tissues and genes. They are divided into somatic cell therapy, gene therapy, tissue engineering products and combination medicines.
Production, logistics and handling are different from a traditional, chemically produced medicine and require specialized expertise, quality assurance and traceability. The regulatory framework for ATMPs is also more extensive given the complexity of the drug group, and includes a unique exception, the so-called hospital exception, where individual patients can be treated in accordance with the doctor's prescription.
- Regulatory framework for advanced therapy medicinal products (lakemedelsverket.se)
- Hospital exemption (lakemedelsverket.se)
Description of advanced therapy medicinal products from the Swedish Medical Products Agency website:
Somatic cell therapy medicinal products
Somatic cell therapy medicinal products contain cells that have been 'substantially processed' so that their biological properties, physiological functions or structural characteristics have been altered and are administered to patients to treat, prevent or diagnose a disease.
Cells and tissues that are not classified as medicinal products are regulated by the National Board of Health and Welfare.
Gene therapy medicinal products
Gene therapy medicines are based on genes (DNA, RNA or other nucleic acid sequence) and are given to patients to regulate, restore, replace, add or remove a gene sequence to treat, prevent or diagnose a disease. Gene therapy medicinal products can also be genetically modified cells, microorganisms or viruses.
Biological medicinal products manufactured by the same or similar genetic engineering methods but used as prophylaxis against infectious diseases are not gene therapy medicinal products but are classified as vaccines.
Tissue engineered product
Tissue engineered products contain processed cells or tissues and are administered for the purpose of regenerating, repairing or replacing human tissue.
In addition to tissue-specific properties, developers of tissue engineered products should also pay attention to non-product-related factors, such as the need for surgical intervention for product implantation and the compatibility of biomaterials with human tissue at the site of implantation.
Combined advanced therapy medicinal products
Combined advanced therapy medicinal products means that the medicine consists of a cell or tissue part and one or more medical devices, such as a matrix or support structures, as an integral part of the medicine.