About Us
Our Mission and Activities
Producer and Distributer of Reference Standards
The Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ) has been registered by the Minister of Health, Labour and Welfare (MHLW) as an organization that produces the Japanese Pharmacopoeia (JP) Reference Standards on the basis of the Ministerial Ordinance (Ordinance of the Ministry of Health, Labour and Welfare No. 117 of 2007), and as such, PMRJ produces and distributes official reference standards used for testing the quality of pharmaceuticals. PMRJ has also been registered as an organization that produces coal-tar color for TLC reference standards in the ministerial ordinance*1 by the MHLW and reference standards for the Japan’s Specifications and Standards for Food Additives*2 by the Prime Minister, and as such, PMRJ produces and distributes those reference standards too.
*1 Ordinance of the Ministry of Health, Labour and Welfare No. 86 of 2004
*2 Public Notice of the Ministry of Health, Labour and Welfare No. 219 of 2004
Misson and Values
The reference standards produced and distributed by PMRJ are used in tests specified in Japanese Pharmacopoeia and other official compendia, serving as national standards for the qualitative and quantitative evaluation of the quality of pharmaceuticals and other products. These reference standards play a critical role by providing the basis for guaranteeing the reliability and objectivity of test results. The Pharmaceutical Reference Standards Center of PMRJ engages in its reference standard work with full awareness of its great responsibility to produce and distribute such reference standards with assurance of their quality.
Process of Reference Standard Production and Distribution
The Pharmaceutical Reference Standards Center of PMRJ is responsible for producing and distributing the reference standards based on the direction by the MHLW. PMRJ strives to ensure their quality and provide a stable supply of them by reliably executing the process shown in the diagram below.
In the establishment of the reference standards, obtaining raw materials of suitable quality for reference standards is critical. We would like to express our sincere appreciation to the companies that have kindly provided the raw materials.
Provision of Technical Information
PMRJ holds training sessions for small numbers of JP users and reference standard users that focus on the JP General Test, such as the Bacterial Endotoxins Test, in order to disseminate practical technical information and exchange technology.
Distributor of USP Reference Standards, etc.
Under a contract with the United States Pharmacopeial Convention (USP Convention), PMRJ distributes United States Pharmacopeia (USP) Reference Standards in Japan. In addition, through LGC Standards GmbH, PMRJ distributes pharmaceutical impurity reference materials handled by that company, European Pharmacopoeia (EP) Reference Standards, British Pharmacopoeia (BP) Reference Standards, and World Health Organization (WHO) International Chemical Reference Substances (ICRS).