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Somatic cell therapy medicinal products and tissue-engineered products (ATMPs)

Somatic cell therapy medicinal products (sCTMPs) and tissue-engineered products (TEPs) are advanced therapy medicinal products (ATMPs). The main difference between sCTMPs and TEPs is determined on the basis of the intended use of the products. Therefore the intended use is part of the definition which is provided below. Both product types are reviewed by CCMO.

Somatic cell therapy medicinal products

Somatic cell therapy medicinal products 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 are intended for the prevention, diagnosis and/or treatment of diseases via pharmacological, immunological or metabolic actions.

The full definition according to the European guidelines is as follows:

Somatic cell therapy medicinal product means a biological medicinal product which has the following characteristics:

  • contains or consists of cells or tissues that have been subject to substantial manipulation so that biological characteristics, physiological functions or structural properties relevant for the intended clinical use have been altered, or of cells or tissues that are not intended to be used for the same essential function(s) in the recipient and the donor;
  • is presented as having properties for, or is used in or administered to human beings with a view to treating, preventing or diagnosing a disease through the pharmacological, immunological or metabolic action of its cells or tissues.

More information can be found in Directive 2009/120/EC, Directive 2003/63/EC part IV and Directive 2001/83/EC Annex I part IV. 

Tissue-engineered products

Tissue-engineered products contain cells or tissues that have been modified so they can be used to repair, regenerate or replace human tissue.

The full definition according to the European guidelines is as follows:

'Tissue-engineered product' means a product that:

  • contains or consists of engineered cells or tissues
    • Cells or tissues shall be considered ‘engineered’ if they fulfil at least one of the following conditions:
      • the cells or tissues have been subject to substantial manipulation, so that biological characteristics, physiological functions or structural properties relevant for the intended regeneration, repair or replacement are achieved.
      • the cells or tissues are not intended to be used for the same essential function or functions in the recipient as in the donor.

and:

  • is presented as having properties for, or is used in or administered to human beings with a view to regenerating, repairing or replacing a human tissue.

More information can be found in article 2(1)(b) of the Clinical Trial Regulation (1394/2007/EG).