Advanced Therapy Medicinal Products (ATMPs)

Advanced therapy medicinal products include transplant products according to the Transplantation Act (e.g. somatic cell therapy products and tissue-engineered products), gene therapy products and other nucleic acid-based products, as defined in the Therapeutic Products Act and taking into consideration the definitions in Article 5 paragraph 2 of the Gene Technology Act (GTA) and Article 3 paragraph 1 letter d of the Release Ordinance (RO; SR 814.911).

According to the Release Ordinance, biologically active genetic materials containing DNA and RNA are equivalent to microorganisms, but are not necessarily regarded as microorganisms. To take this legal environment into account and enable the application of a risk-based approach, the term ATMPs also refers to products with which genetic information is introduced into somatic cells, such as oligonucleotides, vectors, mRNA (including vaccines) and antisense RNA (asRNA). This approach makes simplification of existing requirements that currently apply to biologically active genetic material based on the Release Ordinance possible for certain non-critical nucleic acid 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. To promote the further development of these promising products and facilitate patient access to these therapies, Swissmedic is extending the existing benefit-risk approach to all ATMPs and defining possible simplifications in a guideline. Swissmedic's more comprehensive definition of ATMP products also takes into consideration international developments and defines the appropriate framework for this based on the benefit-risk assessment. In so doing, Swissmedic is making a major contribution to facilitating research with such products in Switzerland over the long term, as well as enabling their rapid availability for patients.

Not only their development, but also the licensing and authorisation processes for innovative therapeutic products are challenging and have to take the particular complexity and individuality of these products into account. ATMPs are medicinal products or products equivalent to medicinal products, and are therefore subject to all the requirements of therapeutic products legislation.

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 advice on 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.

In addition to ATMPs, the new 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.

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New implementing regulations apply as of 1 November 2024

The Federal Council approved the amendments to the ordinances relating to the Human Research Act (HRA) and adopted them on 7 June 2024. The amendments strengthen the protection of persons participating in research and, where possible, improve the regulatory framework for researchers. The amended ordinances enter into force on 1 November 2024, with the exception of the provisions on transparency, which enter into force on 1 March 2025.

Innovation at Swissmedic

Trust the vaccine

Julia Djonova, Head of the Advanced Therapy Medicinal Products division, on mRNA technology.

General overview of Advanced Therapy Medicinal Products, transplants and procedures  

Legal texts

Working documents/forms /instructions /information sheets

  • Authorisations TpP/GT/GMO
  • Establishment licence TpP/GT/GVO
  • GMP and GDP certificates
  • Special licence for non-authorised TpP/GT/GVO
  • Clinical trials TpP/GT/GMO
  • Biovigilance TpP/GT/GMO
  • Autologous transplants
  • Approval of procedures