FAQ - Addictive substances as investigational drugs (GCP)

From a clinical trial perspective, are there any additional requirements if an investigational product (IMP) is an addictive drug (SM)?

From the perspective of submission/approval, clinical trials with addictive substances have no additional requirements compared to clinical trials with non-addictive substances.

However, the provisions of the Narcotic Drugs Act (SMG) and associated ordinances must be observed [Narcotic Drugs Ordinance (SV) and Psychotropic Drugs Ordinance (PV)]. The term narcotic includes narcotic drugs and psychotropic substances (see SV and PV Annexes). A stricter standard applies to addictive drugs.


Further inquiry note