Drug Evaluation Committee 2020-48 Management Records of Investigational Drugs Used in Clinical Trials from the Performing Medical Institutions' Inventory
Related classification: Investigational drugs
First published: Mar. 2021
Question
In the revised GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15), Article 39 Guidance 4 of the GCP states that "With regard to investigational drugs to be used from the inventory kept by the site, the sponsor shall follow the handling, storage, management, prescription, etc. procedures established by the site. The guidance also states that "the sponsor shall prepare and maintain records showing that the quantities of all investigational new drugs have been properly managed.
We would like to know whether strict lot and inventory control is required for investigational drugs that are not delivered by the sponsor but are stored as inventory by the site, or whether it is necessary to keep a record of such drugs in writing.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stated in the applicable GCP guidance, for investigational drugs other than investigational drugs that are not delivered by the sponsor and are used from among those stored as inventory by the site, it is basically acceptable to follow the procedures for handling, storage, management, prescription, etc. established by the site. However, it is acceptable to handle them in accordance with the procedures for handling, storage, management, prescribing, etc. established by the site. However, since it is necessary to prepare and store records showing that appropriately stored and managed investigational drugs were administered to subjects in the quantities specified in the protocol, we believe that records such as receipt and delivery records that show which subjects and in what quantities the investigational drugs were used are necessary. It is recommended to discuss with the sponsor in advance what information, including lot numbers, should be kept in the record.