Drug Evaluation Committee 2008-43 Use of Carriers by CROs in the Delivery of Investigational New Drugs
Related classification: clinical trial contracting procedures
Date of first publication: Mar. 2009
Question
If a CRO is entrusted by a sponsor to store and manage investigational new drugs and ship them to a site, is it acceptable for the CRO to entrust the shipping to the site to a carrier and enter into a two-party contract with the CRO and the carrier?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 17 Guidance 5 of the GCP states that "When delivering investigational new drugs to a site using a carrier, the sponsor shall take necessary measures such as concluding a contract with the carrier to ensure quality control, transport and delivery of the investigational new drug. The above is a requirement for the CRO and the sponsor. Therefore, if the sponsor and the CRO have an agreement that the CRO will re-consign the entrusted work to the carrier, and if the sponsor confirms that the work entrusted by the sponsor to the CRO will be reliably performed according to the contract between the CRO and the carrier and the work procedures, etc., then the CRO and the carrier must conclude a second-party agreement to ensure that the CRO will perform the work entrusted to it, A two-party contract between the CRO and the transporter would be acceptable.