ICHPharmaceutical Regulations in Japan

Workshop on the ICH M7 Guideline (JPMA, Tokyo)

Workshop on the ICH M7 Guideline was held in Japan which took place at JPMA office in Tokyo on September 29, 2014.
This workshop aimed to provide the explanation of ICH M7, Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk which had reached Step 4 as ICH harmonized tripartite guideline. And now, it enters in implementation period (Step5). The workshop was organized by the Japan Pharmaceutical Manufacturers Association (JPMA). All the information as well as the presentation used at the symposium in Japanese is available as below.
Working Language: Japanese
Simultaneous English-Japanese Translation: Not Available
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Location: Japan Pharmaceutical Manufacturers Association (JPMA)
       Nihonbashi Life Science Bldg.,2-3-11 Nihonbashi-Honcho,Chuo-ku,Tokyo
Date: September 29, 2014   1:30 pm ~4:00 pm

Program Chair:Masamitsu Honma, MHLW (NIHS)
          Tsuneo Hashizume, JPMA

  Presentation materials Speakers
13:30-13:35 Welcoming Address Hironobu Saito, JPMA
13:35-13:45 Background to reach Step 4 (PDF 264KB) Kazusehi Komatsu, JPMA
13:35-14:00 Safety Issue (PDF 444KB) Hisami Hiragi, MHLW (PMDA)
14:00-15:00 Implementation and Quality Issue (PDF 259KB) Junichi Fukuchi, MHLW (PMDA)
14:45-15:00 Future Prospect and Issues from Industry Position
(PDF 217KB)
Tsuneo Hashizume, JPMA
15:15-16:00 Questions and Answers

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