Pmda.go.jp

Pharmaceuticals and Medical Devices Agency

WebApril 26, 2024. Int. New. PMDA Updates (April, 2024) posted. April 25, 2024. Safety. New. MHLW Pharmaceuticals and Medical Devices Safety Information No.409 posted

Actived: 1 days ago

URL: https://www.pmda.go.jp/english/

Outline of PMDA Pharmaceuticals and Medical Devices …

WebPMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare. Our obligation is …

Category: Medical Go Health

Frequently Asked Questions (FAQ) Pharmaceuticals and …

WebQ9-3. I would like to know how to import/supply/use of unapproved drugs or medical devices for clinical trials. In order to import unapproved drugs or medical devices for the use of …

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Review Reports: Drugs Pharmaceuticals and Medical …

WebPMDA shall not be responsible for any consequence resulting from use of the English versions. The review reports were selected for translation among those of drugs with a …

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MDSAP Pharmaceuticals and Medical Devices Agency

WebThe Medical Device Single Audit Program (MDSAP) is intended to allow MDSAP Auditing Organizations to conduct a single audit of a medical device manufacturer that will satisfy …

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Notifications Related to Safety Measures (drugs)

WebNotifications issued by the MHLW related to safety measures for drugs are listed here. Date. Title. Original in Japanese. PMDA/CSO No.60. February 17, 2023. Points to Consider, …

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Pharmaceuticals and Medical Devices Safety …

WebThis English version of PMDSI is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English …

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MHLW Pharmaceuticals and Medical Devices Safety …

WebPharmaceuticals and Medical Devices Safety Information (PMDSI) is issued based on safety information collected by the Ministry of Health, Labour and Welfare .It is intended to …

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The new purpose established on the 20th anniversary …

WebNews 1. The new purpose established on the 20th anniversary of the PMDA On April 1, 2024, the PMDA celebrated its 20th anniversary. The PMDA started to operate as a …

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Regulation for Regenerative Medicinal Products

WebPharmaceuticals and Medical Devices Agency. Regulation for Regenerative Medicinal Products. Yoshiaki Maruyama, Ph.D. Director, Office of Cellular and Tissue-based …

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For Sponsors of GLP Studies Pharmaceuticals and Medical

WebFees for product-based inspections for drugs, medical devices, and regenerative medical products are 3,606,200, 3,545,600, and 4,057,000 JPY, respectively, which should …

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Japan’s NHI Drug Price System

WebMeaning of the Universal Health Insurance System Our country has realized the world’s highest level of life expectancy and healthcare standards through the universal health …

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Master File System Pharmaceuticals and Medical Devices Agency

WebThe Drug Master File (DMF) System, allows the manufacturers of Active Pharmaceutical Ingredients (APIs) to submit the detailed information (manufacturing methods, data, etc.) …

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Japanese Pharmacopoeia 18th Edition Pharmaceuticals and …

WebThe Japanese Pharmacopoeia Drugs are to be tested according to the provisions given in the pertinent monographs, General Notices, General Rules for Crude …

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Kasumigaseki わかる！MID-NET

WebPossible to utilize multiple types of data Information that can be handled on MID-NET® NCDA※1：Approximately 4.45 million patients （as of September 2023） ※1 Database …

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Revision of Japanese Medical Device QMS requirements

WebThe Japanese medical device Quality Management System requirements are stipulated in MHLW Ministerial Ordinance No. 169 (2004) titled "the Ministerial Ordinance …

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Safety Alert & Recalls/ Review Reports/ Package Inserts etc

WebJCN 3010005007409. Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan

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Regulatory Information Pharmaceuticals and Medical Devices …

WebNew Regulations of Non-Corrective Colored Contact Lenses under the Pharmaceutical Affairs Law. Issuance of Certificates for Medical Devices for Export. Revision of …

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