Advanced Therapy Medicinal Product Explained

Advanced Therapy Medicinal Products, or ATMPs, are advanced therapeutic drugs that are based on cell therapy or gene therapy (sometimes in combination with a medical device - where they are then called a tissue engineered product). The criteria to which a drug must conform to be classified as an ATMP, are defined in Article 17 of Regulation (EC) No 1394/2007 by the European Commission.[1]

Notes and References

  1. Web site: Archived copy . 2020-11-01 . 2020-09-20 . https://web.archive.org/web/20200920181350/https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2007_1394/reg_2007_1394_en.pdf . dead .