What are ATMPs?

Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, cells or tissue engineering. This is a European classification through the European Medicines Agency (EMA).

Traditional transplants involve removing cells or tissue from the patient or from a donor and transferring them to the patient in a way that they perform the same funtion eg.

Advanced Therapy Medicinal Products (ATMPs) vary from traditional transplant in at least one of the following ways;

The official definitions of ATMPs from the EMA can be found in our ATMP regulatory guide here.

There are 4 types of ATMP;

  1. GTMP – gene therapy medicinal product
  2. sCTMP – somatic cell therapy medicinal product
  3. TEP – tissue engineered product
  4. cATMP – combined ATMP

Find more information on these below!

Gene Therapy Medicinal Product (GTMP)

Essentially all ’gene therapies’ are subclassified as GTMPs.

To be a GTMP the medicine must have both;

GTMPs do not include vaccines against infectious diseases.

The following are GTMPs approved by the European Medicines Agency (EMA).

Imlygic – Unresectable Melanoma
Strimvelis – ADA
Yescarta CAR-T – non-Hodgkin lymphoma
Zalmoxis – avoiding infection after bone marrow transplantation

Somatic Cell Therapy Medicinal Product (sCTMP)

sCTMPs contain cells or tissues that have altered characteristics or will not be used for the same essential functions in the body.

sCTMPs can be used to cure, diagnose or prevent diseases.

To be a sCTMP a medicine must both:

The following are sCTMPs approved by the EMA.

Alofisel – perianal fistulas in Crohn’s disease

Holocar – severe cornea damage

Tissue Engineered Product (TEP)

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

A TEP has the following characteristics:

The following is an EMA approved TEP.

Spherox – knee cartilage defects

Combined ATMP (cATMP)

Combined ATMPs contain one or more medical devices as an integral part of the medicine.

An example of a cATMP would be cells embedded in a biodegradable matrix or scaffold.

A combined ATMP must incorporate, as an integral part of the product, one or more medical devices within the meaning of Article 1(2)(a) of Directive 93/42/EECor one or more active implantable medical devices within the meaning of Article 1(2)(c) of Directive 90/385/EEC.

As well as either;
1. contain viable cells or tissues.
2. contain non-viable cells or tissues liable to act upon the human body with action that can be considered as primary to that of the devices referred to.