Agreement on Provision and Transfer of Control Drugs
The collection and preparation of clinical trial data is necessary for the application for approval, etc. (including reexamination and reevaluation) of pharmaceutical products. For this purpose, pharmaceutical companies conduct a variety of clinical trials. Among these, "comparative studies," in which the efficacy and safety of a new drug is evaluated by directly comparing a drug that has already been approved and is on the market with a new drug that is about to be submitted, is a very important element of clinical trial data. In comparative studies, the marketed drug used for comparison and contrast with the new drug is called the "control drug. In order for a pharmaceutical company developing a new drug to conduct a comparative study, it must obtain a control drug from a partner company that manufactures and sells the drug as a marketed product. The "Agreement on the Provision and Transfer of Control Drugs" was established as a voluntary agreement among the member companies of the Pharmaceutical Manufacturers Association of Japan (PMAJ) to ensure the smooth implementation of the provision and transfer of control drugs used in comparative studies.
The "Agreement on the Provision and Transfer of Controlled Drugs" was established in July 1981 and has been revised three times since then, with the fourth revision coming into effect on November 1, 2005.
We plan to continue to revise it as necessary to ensure the smooth implementation of comparative studies in Japan.