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Japanese

Pharmaceutical and Medical Device Regulatory Science Society of Japan


    Mission
    Outline of Activities
    Locations

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:
  1. Publication of our monthly 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
  2. Production and distribution of JP Reference Standards for pharmaceuticals
  3. Organizing educational meetings with the purpose of providing cutting-edge information on drugs and medical devices and the venue to exchange different views
  4. Conducting technical editing of proposed draft JP texts under the guidance of the Pharmaceuticals and Medical Devices Agency (PMDA)
  5. Maintenance and distribution of Medical Dictionary for Regulatory Activities, Japanese version (MedDRA/J), an ICH product
  6. Providing research grants related to testing methods and specifications of pharmaceutical drugs in JP
  7. Providing research grants related to promotion of Regulatory Science
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Outline of Activities


  1. Publications  =>more
    • The Japanese Pharmacopoeia 16th ed. (JP16; in English)
    • Japanese Pharmacopoeial Forum: A quarterly journal (JPF: in Japanese and English)
    • Pharmaceutical and Medical Device Regulatory Science: A monthly 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)
    Contact : e-mail


  2. Reference Standards
       The Reference Standards which are used for the tests of drugs and food additives listed in official compendia are established by MHLW (Ministry of Health, Labour and Welfare). We are a registered producer of these Reference Standards. The USP (United States Pharmacopeia) Reference Standards are also available through the Society.   =>more
    • JP Reference Standards and other reference standards
    • USP Reference Standards
    Contact : => here


  3. Educational Meetings  =>more
       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 (biannually)
    • Results of the latest meetings in ICH
    Contact : e-mail


  4. JMO Activities (MedDRA Japanese Maintenance Organization)
       MedDRA was developed under the auspices of ICH, and is maintained by MSSO (Maintenance and Support Services Organization (http://www.meddramsso.com/)) 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.
    Contact : http://www.pmrj.jp/jmo/php/indexe.php
             Contact : e-mail


  5. Others
    • Providing research grants related to testing methods and specifications of pharmaceutical drugs in JP
    • Providing research grants related to promotion of Regulatory Science
    Contact : e-mail
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Locations


Shibuya Head Office
Location :  2-12-15, Shibuya, Shibuya-ku, Tokyo 150-0002, Japan
    TEL : +81 3 3400 5634; FAX : +81 3 3400 3158

map of Society

  
Osaka Office
Location :   2-1-2, Hiranomachi, Chuo-ku, Osaka-city, Osaka 541-0046, Japan
    TEL : +81 6 6221 3444; FAX : +81 6 6221 3445 (Office)
    TEL : +81 6 6221 3458; FAX : +81 6 6221 3459 (Order Receiving & Shipping Desk)

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(Last update: 08-July-2015)