Drug Evaluation Committee 2012-21 Packaging and Labeling of Controlled Drugs, Designated Concurrent Drugs, and Basic Therapeutic Drugs Provided by the Sponsor

Related classification: Other

First published: August 2012

Question

Please tell us about the provision, packaging and labeling of over-the-counter drugs used in clinical trials to the investigational sites.

Question 1

When we purchase an over-the-counter drug from the market and provide it to a site as a "control drug," is it possible to provide the drug in the same packaging and labeling as it was purchased from the market? Also, is it necessary for the sponsor's office that stores and dispatches the "control drug" to obtain a pharmaceutical wholesaler's license? If the product must be placed in a white box, is it acceptable to place the purchased product in a white box with the packaging and labeling as it is sold on the market, and the labeling on the white box should be "plain" (for example, assuming the case where a brand-name drug is purchased from the market in order to conduct a bioequivalence study for the purpose of applying for a generic drug)? Also, in the case of just placing the drug in a white box, would it be acceptable to do quality assurance based on the concept that "the quality of the drug should not be affected because it was only placed in a white box after being distributed to the market by another company (the manufacturer or distributor) with responsibility for its quality"? Article 2 of the GCP Ministerial Ordinance defines a control drug as an investigational drug, and Article 16 of the GCP Ministerial Ordinance stipulates that an investigational drug must be labeled as an investigational drug. In this way, even if an over-the-counter drug purchased from the market is used as a control drug, it is still an investigational drug, and it would be a violation of GCP if it were packaged and labeled as an over-the-counter drug. . How do companies handle such situations as when conducting bioequivalence studies?

Question 2

If an over-the-counter drug is purchased from the market and provided to a clinical trial site as a "concomitant drug" or "basic therapeutic drug," is it possible to provide the product with the same packaging and labeling as it was purchased from the market? If so, is it necessary for the office of the sponsor that stores and dispatches the "concomitant drug" or "basic therapeutic drug" to obtain a pharmaceutical wholesaler license? If the product must be placed in a white box, is it acceptable to place the purchased product in a white box with the commercial packaging and labeling, and the labeling on the white box should be "plain"?

Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)

Question 1

Since the case in question is a case where the sponsor purchases a marketed drug from the market and uses it as a control drug in a clinical trial, I would like to express my opinion by excluding the following cases.

As stipulated in GCP Article 2, Paragraphs 6 and 7, the control drug must be handled as an investigational drug. In addition, the labeling and management of the investigational drug must be in accordance with GCP Article 16.

Usually, the marketed product or its accompanying documentation lists the product name, indications, and dosage and administration. For investigational drugs, on the other hand, the "intended trade name," "intended efficacy," and "intended dosage and administration" of the investigational drug (hereinafter referred to as "intended trade name of the investigational drug") are prohibited items, and these prohibited items apply not only to the outer packaging of the investigational drug but also to the drug itself and its packaging (including the inner bag). This prohibition applies not only to the outer packaging of the investigational drug but also to the investigational drug itself and its packaging (including the inner bag) (GCP Article 16.2). Therefore, the sponsor should determine the packaging of the control drug (whether it is acceptable to simply place the marketed product in a white box) in light of this prohibition.

When purchasing control drugs (ethical drugs) from the market, a pharmaceutical wholesaler license is required. In the management of such drugs, the sponsor should determine the method of storage with a feasible management system, taking into consideration the principle of storage in a place designated by the pharmaceutical wholesaler's license.

Question 2

Of the drugs used in a clinical trial as defined in the protocol, those that do not fall under the category of investigational drugs do not need to be packaged and labeled as investigational drugs. A pharmaceutical wholesaler license is required for the purchase of such drugs. In the management of such drugs, the sponsor should determine the method of storage with a feasible management system, taking into consideration the principle of storage at the location designated by the pharmaceutical wholesaler license.

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