Regulation of advanced therapies in the EU (ATMP)
Medicinal products for advanced therapies are regulated according to the ATMP Regulation 2007/1394/EC
This page informs about the ATMP regulation in the EU and provides an overview over relevant contact points for additional information regarrding the development of avanced therapy medicinal products.
Definitions from REGULATION (EC) No 1394/2007 on advanced therapy medicinal products
ATMP (Advanced Therapy Medicinal Products) are biological medicinal products based on cells, tissue and genes. They are divided in gene therapy medicinal products, somatic cell therapy medicinal products, tissue engineered products and combined advanced therapy medicinal products.
Gene therapy medicinal products
as defined in Part IV of Annex I to Directive 2001/83/EC, chapter. 2.1
Gene therapy medicinal product means a biological medicinal product which has the following characteristics:
(a) it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence;
(b) its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence.
Gene therapy medicinal products shall not include vaccines against infectious diseases
Somatic cell therapy medicinal product
as defined in Part IV of Annex I to Directive 2001/83/EC, chapter 2.2
Somatic cell therapy medicinal product means a biological medicinal product which has the following characteristics:
(a) 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; (b) 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. For the purposes of point (a), the manipulations listed in Annex I to Regulation (EC) No 1394/2007, in particular, shall not be considered as substantial manipulations.
Tissue engineered product
as defined in the ATMP REGULATION (EC) No 1394/2007, point (b):
Tissue engineered product means a product that:
— contains or consists of engineered cells or tissues, 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.
A tissue engineered product may contain cells or tissues of human or animal origin, or both. The cells or tissues may be viable or non-viable. It may also contain additional substances, such as cellular products, bio-molecules, biomaterials, chemical substances, scaffolds or matrices.
Is it a medicinal product? Ask DKMA
Is it an ATMP? Ask EMA
Regulatory advice from DKMA: National scientific advice:
Regulatory advice from EMA:
Good Manufacturing Practice (GMP)
Legislation on GMP and GDP:
GMP for ATMP:
Clinical trials of medicines in Denmark
Particular demands for first-in-human clinical trials:
EMA guideline on documentation requirements regarding ATMP in clinical trials:
EMA guidelines regarding ATMP:
EDQM guide to the quality and safety of tissues and cells for human application:
Contact point for the clinical trial department:
Telephone: 4488 9123 / mail: clinical trials
Compasionate use permits
Compasionate use permits for medicinal products that is not marketed in Denmark:
Other regulatory authorities responsibility
The Danish Patient Safety Authority: Regulation of tissue and cell procurement
The Danish Environmental Protection Agency: Regulation of GMO
Work environment in Denmark