Advanced therapy medicinal products (ATMPs) consist of products that contain recombinant nucleic acids or engineered cells and/or tissues representing a paradigm shift in health care as they have great potential for preventing and treating many diseases.
These products are divided into four subcategories:
- somatic cell therapy medicinal products (SCTMP)
- tissue-engineered products (TEP)
- gene therapy medicinal products (GTMP)
- combined ATMPs (cATMPs).
The cATMPs consist of one of the first three categories combined with one or more medical devices as an integral part of the product.
Regulation 1394/2007/EC provides the overall framework on ATMPs for those products, which are intended to be placed in the market of EU Member States. In addition, Directive 2009/120/EC updated the definitions and detailed scientific and technical requirements for advanced therapies.
In April 2021 the European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) delivered new scientific recommendations on whether a medicine can be classified as ATMP. The list of medicines that the CAT has assessed and recommended classifying as ATMPs or not since January 2021 is available. (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/advanced therapies/advanced-therapy-classification/scientific-recommendations-classification-advanced-therapy-medicinal-products).
ATMPs represent a fast-growing field of interest. Although most of the products are in an early development phase, the combined trial phase and the potential to cure severe chronic conditions suggest that ATMPs may reach the market earlier than standard therapies. Targeted therapies have opened the way for new trial methodologies, from which ATMPs could benefit to get early access.
“RPN has successfully supported clients developing ATMPs in the early dialogue with EMA and national Authorities, in the registration process through the centralized procedure and in the Market Access in Europe with innovative schemes”.