Cellular and tissue-based products approval and licensing procedures in Japan = 再生医療等製品製造販売指針

• Material Type: 図書
• ISBN: 978-4-8407-5081-3
• Title: Cellular and tissue-based products approval and licensing procedures in Japan
• Title Transcription: Cellular and tissue-based products approval and licensing procedures in Japan
• Publication, Distribution, etc.: Tokyo : Jiho
• Publication Date: 2018.7
• Publication Date (W3CDTF): 2018
• Extent: 21, 560p
• Size: 30cm
• Alternative Title: 再生医療等製品製造販売指針 サイセイ イリョウ トウ セイヒン セイゾウ ハンバイ シシン
• Place of Publication (Country Code): JP
• Text Language Code: eng
• NDLC: AZ-581
• Target Audience: 一般
• Collection (particular): 日本関係外国語図書
• Price: 180000円
• Holding library: 国立国会図書館
• Call No.: AZ-581-B16
• Data Provider (Database): 国立国会図書館 : 国立国会図書館蔵書; https://ndlsearch.ndl.go.jp
• Bibliographic ID (NDL): 029063078; http://id.ndl.go.jp/bib/029063078
• National Bibliography No. (JPNO): 23098244
• Cataloging Rule: Nippon Cataloguing Rules 1987 Revised Edition
• Bibliographic Record Category (NDL): 111

• Summary, etc.: ●「再生医療等製品製造販売指針」の完全英訳版。海外との業務提携、グローバルオフィスとのコミュニケーションに最適！(Provided by: 出版情報登録センター（JPRO）)

Table of Contents

Part I　Outline of Pharmaceutical Regulations According to the Pharmaceutical and Medical Device Act

Part II　Marketing Approval

Part III　Materials, etc., Drug Master File, and Accessory Ingredients

Part IV　Procedures from Marketing Approval Application to Approval

Part V　Clinical Trials, Face-to-face Consultation, Orphan Cellular and Tissue-based Products, and Co-Development