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Meeting Report: Current Issues in QA of Medicinal Products in Japan

Summary: The annual meeting on QA and GMP issues related to medicinal products regulated in Japan, focused
on two major topics: recent amendments to the JP XIV and the forthcoming enforcement on April 1, 2005 of 
the revised Pharmaceutical Affairs Law - click here for more

Series   Document   Contents
Japan Monitor

(ISSN 1550-3429)


  1. Second supplement to the Fourteenth Edition of the Japanese Pharmacopoeia (administrative viewpoint) - MHLW, PFSB, Evaluation and Licensing Division

  2. Second Supplement to the Fourteenth Edition of the Japanese Pharmacopoeia (reviewer viewpoint) - National Institute of Health Sciences

  3. GMP compliance for medicinal products - Tokyo Metropolitan Government, Bureau of Social Welfare and Public Health, Medical Welfare Division

  4. Recent trends in GMP - National Institute of Health Sciences, Division of Drugs

  5. Current issues of the pharmaceutical inspections: Recall of the medicinal products and the violations of the Pharmaceutical Affairs Law - MHLW, PFSB, Compliance and Narcotics Division


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  • 27 pages extended description and comments of all presentations

  • 3 illustrations (2 diagrams, 1 table)

  • Comments and annotations

  • Links, further reading

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