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Actions concerning Applications for Marketing Approval related to the Period of Transitional Measures with respect to the Handling of Medical Device Software
$15.00
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ADMINISTRATIVE MEASURES FOR DRUGS IMPORTATION (Order No. 4)
$350.00 $300.00
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ADMINISTRATIVE MEASURES FOR DRUGS REGISTRATION – (Order No. 28)
$350.00 $300.00
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Administrative Measures for the Communication with CDE During Drug R&D and Technical Evaluation, Order No.48,2020
$200.00 $100.00
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AGREEMENT OF PROHIBITED AND PERMITTED PLANTS THAT ARE DETERMINED FOR TEAS, INFUSIONS, EDIBLE VEGETABLE OILS AND FOOD SUPPLEMENTS.
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AGREEMENT OF PROHIBITED AND RESTRICTED SUBSTANCES DETERMINED IN THE PRODUCTION OF PERFUMERY AND BEAUTY PRODUCTS.
$300.00
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Announcement of the State of Food Drug Administration on the Issuance of Working Procedures for Review of Breakthrough Therapies No.82, 2020
$200.00 $100.00
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Announcement on Approval of Active Pharmaceutical Ingredients (API), Pharmaceutical Excipients and Pharmaceutical Packaging Materials for Drug Products No.146, November 30, 2017
$100.00
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Announcement on Further Improving Related Issues Concerning Drug Evaluation, Approval and Supervision (DMF for API, Pharmaceutical Packaging Materials and Excipients)(No. 56 of 2019), July 15, 2019
$100.00
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Announcement on Record Filling of Medical Device Master Files
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Application for Marketing Authorization for Medical Devices in Japan
$30.00 $15.00
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Application for Accreditation of Foreign Manufacturers to PMDA in Japan
$30.00 $15.00
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Applications for Marketing Approval of In Vitro Diagnostics
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Basic Principles of Global Clinical Trials in Japan
$50.00 $30.00
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Best Practices in Developing Proprietary Names for Human Prescription Drug Products
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C-Reactive Protein Assay Kit Registration Technical Review Guideline
$100.00
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