Transcription of Regulation of Regenerative Medicine in Japan - Pmda
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Regulation of Regenerative Medicine in Japan - Pmda
Regulation of Regenerative Medicine in Japan Yoshiaki Maruyama Review Director, Office of Cellular and Tissue-based Products PMDA, Japan Outline The Act on the Safety of Regenerative Medicine (Safety Act). The Act on Pharmaceuticals and Medical Devices (PMD Act). Evolving Early Access Schemes Develop Guidelines Regulatory Framework for Regenerative Medicine in Japan Regenerative Medicine All medical technologies using Production and marketing of processed cells which safety and Regenerative and cellular efficacy have not yet been therapeutic products by firms established The Act on the Safety of The Act on Pharmaceuticals and Regenerative Medicine (Safety Act) Medical Devices (PMD Act). Medical Care or Clinical Research Commercial Product Marketing Authorization Purpose Organizations and Authorities in Japan MHLW Safety Act Health Policy Bureau Health and Welfare Branches Certified committees Pharmaceutical and PMD Act Environmental Health Bureau Hospitals Approval Decision, License Execution Manufactu PMDA MAHs ring Sites CPFs Office of Cellular and Tissue based Products Product Review Office of Manufacturing Quality and Compliance Office of Safety I Site Inspections Outline The Act on the Safety of Regenerative Medicine (Safety A)
An explanation document used for informed consent and consent form Sample of “Case Report Form” Current investigator's brochure •Timing The first notifications; 31 days before (others; 2 weeks before) Cell therapy Gene therapy Total 46 15 …
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