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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
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ADMINISTRATIVE MEASURES FOR DRUGS IMPORTATION (Order No. 4)
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ADMINISTRATIVE MEASURES FOR DRUGS REGISTRATION – (Order No. 28)
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Administrative Measures for the Communication with CDE During Drug R&D and Technical Evaluation, Order No.48,2020
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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.
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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
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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
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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
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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
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Application for Accreditation of Foreign Manufacturers to PMDA in Japan
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Applications for Marketing Approval of In Vitro Diagnostics
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Basic Principles of Global Clinical Trials in Japan
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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
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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

ADMINISTRATIVE MEASURES FOR DRUGS IMPORTATION (Order No. 4)

ADMINISTRATIVE MEASURES FOR DRUGS REGISTRATION – (Order No. 28)

Administrative Measures for the Communication with CDE During Drug R&D and Technical Evaluation, Order No.48,2020

AGREEMENT OF PROHIBITED AND PERMITTED PLANTS THAT ARE DETERMINED FOR TEAS, INFUSIONS, EDIBLE VEGETABLE OILS AND FOOD SUPPLEMENTS.

AGREEMENT OF PROHIBITED AND RESTRICTED SUBSTANCES DETERMINED IN THE PRODUCTION OF PERFUMERY AND BEAUTY PRODUCTS.

Announcement of the State of Food Drug Administration on the Issuance of Working Procedures for Review of Breakthrough Therapies No.82, 2020

Announcement on Approval of Active Pharmaceutical Ingredients (API), Pharmaceutical Excipients and Pharmaceutical Packaging Materials for Drug Products No.146, November 30, 2017

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

Announcement on Record Filling of Medical Device Master Files

Application for Marketing Authorization for Medical Devices in Japan

Application for Accreditation of Foreign Manufacturers to PMDA in Japan

Applications for Marketing Approval of In Vitro Diagnostics

Basic Principles of Global Clinical Trials in Japan

Best Practices in Developing Proprietary Names for Human Prescription Drug Products

C-Reactive Protein Assay Kit Registration Technical Review Guideline

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