Swissmedic imposes stricter requirements on the documentation of GMP compliance for this product class.

ATMPs are complex medicinal products for novel therapies based on genes (gene therapy medicinal products), tissues (tissue engineered products) or cells (somatic cell therapy medicinal products). These may be of human or xenogeneic (from another species, foreign) origin and may be combined with medical devices. ATMPs are subject to both the Transplantation Act and the Therapeutic Products Act. At Swissmedic, the ATMP department, newly established at the beginning of 2022, is responsible for assessing the quality, safety and efficacy of ATMPs.

Due to the complexity and novelty of this product class, there are stricter requirements for their authorization in particular, the documentation confirming GMP compliance, among other things.

In addition to the submission of GMP certificates for the manufacturers of active ingredients, finished products and quality control, Swissmedic also requires GMP certificates from:

Manufacturers of intermediate products of the finished product,
Manufacturers of critical excipients (e.g. human serum albumin).

In the case of critical excipients, Swissmedic also requires information on their extraction and details of the individual manufacturing steps.

Authorisation of ATMP (Advanced Therapy Medicinal Products)

Your contact