Pharmaceutical and Medical Device Regulatory Science Society of Japan
Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ) is a non-profit general incorporated foundation formerly known as Society of Japanese Pharmacopoeia established in June 1956. Our mission is to promote better quality, efficacy, and safety of drugs and medical devices by advancing their regulatory sciences.
Mission of the Society
Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ) is a non-profit general incorporated foundation with the objectives of advancing Regulatory Science related to drugs and medical devices. Thus, we intend to promote better quality, efficacy and safety of medical products.
The main activities which we conduct to meet these objectives are as follows:
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01
Publication of our bimonthly journal, PMDRS (Pharmaceutical and Medical Device Regulatory Science) and documents on pharmaceutical standards, such as Japanese Pharmacopoeia (JP) in English as well as in Japanese
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02
Production and distribution of JP Reference Standards for pharmaceuticals
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03
Organizing educational meetings with the purpose of providing cutting-edge information on drugs and medical devices and the venue to exchange different views
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04
Conducting technical editing of proposed draft JP texts under the guidance of the Pharmaceuticals and Medical Devices Agency (PMDA)
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05
Maintenance and distribution of Medical Dictionary for Regulatory Activities, Japanese version (MedDRA/J), an ICH product
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06
Providing research grants related to testing methods and specifications of pharmaceutical drugs in JP
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07
Providing research grants related to promotion of Regulatory Science
Outline of Activities
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Publications
○ The Japanese Pharmacopoeia 18th ed. (JP18; in English)
○ Japanese Pharmacopoeial Forum: A quarterly journal (JPF: in Japanese and English)
○ Pharmaceutical and Medical Device Regulatory Science: A bimonthly journal (mainly in Japanese) (former titles: “IYAKUHIN KENKYU” until March 2004; “Pharmaceutical Regulatory Science” from April 2004 to December 2009)
○ Japanese Pharmacopoeia Technical Information (JPTI; in Japanese)
○ The Japanese Pharmaceutical Codex 2002 (JPC2002; in Japanese)
○ Japanese Orange Books (Approved drug products with therapeutic equivalence evaluations; in Japanese) -
Reference Standards
PMRJ has been registered by the Minister of Health, Labour and Welfare or the Prime Minister as an organization that produces and distributes Japanese Pharmacopoeia (JP) reference standards, Ministerial Ordinance coal-tar color for TLC reference standards, and Japan’s Specifications and Standards for food additives reference standard.
Under a contract with the USP Convention, PMRJ distributes United States Pharmacopeia (USP) Reference Standards in Japan. In addition, through LGC Standards GmbH, PMRJ distributes pharmaceutical impurity reference materials, European Pharmacopoeia (Ph. Eur.) Reference Standards, and other reference standards.Educational Meetings
PMRJ holds Educational Meetings periodically to provide the following information that will enable interested parties to acquire the expertise needed in their line of work.
○ Up-to date information on development, pharmacovigilance (PV), quality control, emerging science and technologies on drugs and medical devices
○ Development of JP monographs, general test methods and others
○ Results of the latest meetings in ICHJMO Activities (MedDRA Japanese Maintenance Organization)
MedDRA was developed under the auspices of ICH, and is maintained by MSSO (Maintenance and Support Services Organization (https://www.meddra.org/)) and JMO. The responsibilities of the JMO are to maintain and to distribute MedDRA in the Japanese language (MedDRA/J) synchronized with English version, and to promote the standardized utilization in Japan.
Research Grants
○ Providing research grants related to testing methods and specifications of pharmaceutical drugs in JP
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○ Providing research grants related to promotion of Regulatory Science
