Drug Evaluation Committee 2023-51 Administration of Investigational Drugs at Related Clinics
Related classification: Outsourcing
Date of first publication: Mar 2024
Question.
We are considering whether we can treat our affiliated clinic as a home nursing station, etc., and administer the investigational drug at the affiliated clinic, since transportation to the site is inconvenient. If it is treated as a home nursing station, etc., would there be any problem if we treat the affiliated clinic as an SMO?If so, please advise us of any precautions we need to take.
Opinion of the Pharmaceutical Association of Japan
The administration of an investigational drug at a medical institution, such as an affiliated clinic, is an act of clinical trial. Therefore, when administering an investigational drug at a medical institution, it is necessary to submit a notification of clinical trial as a medical institution conducting the clinical trial and to conclude a clinical trial agreement with the sponsor based on Article 13 of the GCP. In addition, according to the report of the Study Group for Establishing Standard Guidelines for the Use of SMOs (Ministry of Health, Labour and Welfare, November 2002), operations that are legally restricted under the Medical Service Act, Worker Dispatching Act, etc. are considered as operations that cannot be performed by an SMO.Article 15-3 of the Medical Care Act does not specify drug administration services as a service that can be outsourced by medical institutions, and from this, we believe that outsourcing this service from a medical institution is not possible.