Advanced therapy medicinal products (ATMPs) include gene therapy products, somatic cell therapy products and tissue engineered products. ATMPs offer a beacon of hope for many patients with diseases that have failed to respond to conventional therapeutic approaches to date. Innovative gene- or cell-based products open up new avenues for the treatment of severe, as yet untreatable or chronic diseases.
In addition to their development, the licensing and authorisation processes for innovative therapeutic products are challenging and have to take their particular complexity and individuality into account. ATMPs are equivalent to medicinal products and are therefore also subject to the Therapeutic Products Act.
The Advanced Therapy Medicinal Products (ATMP) division, which emerged from the Transplants (TpP) unit on 1 January 2022, is responsible for the regulatory and scientific supervision of ATMPs and related products or processes. The ATMP division promotes research and development in this area and provides scientific and procedural advice (scientific advice/pre-submission meetings).
By bundling these activities, Swissmedic is creating an innovation-promoting framework to give patients the fastest possible access to effective, high-quality and safe advanced therapy medicinal products.
The ATMP division is also responsible for products and procedures whose properties are comparable with gene therapy products and which require comparable development approaches and specialist knowledge. These include products in which genetic information such as oligonucleotides, mRNA and antisense RNA (asRNA) is introduced into somatic cells. The division also processes autologous transplants and other novel therapies such as bacteriophages, microbiota transfer, blood and pathogen inactivation procedures and procedures for non-standardisable medicinal products.
The ATMP division also carries out inspections, issues establishment licences, assesses investigational medicinal products and approves clinical studies, takes decisions on authorisation applications and monitors the relevant products following marketing authorisation.