●「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！ 再生医療等製品の製造販売承認・許可制度について，その手続きや留意点を解説した「再生医療等製品製造販売指針」の完全英訳版。本文解説から付録まで完訳収載し，巻頭掲載の英和対訳目次は、和文書籍・英文書籍相互のページ数を記載。判型も和文書籍と同様のA4判として、和文・英文相互の整合性・利便性を高めています。 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 Part VI　License for Marketing Authorization Holder Part VII　Manufacturing Business License and Accreditation Part VIII　Exporting/Importing Appendix 1　Standards for Bio-derived Materials Appendix 2　List of the Number of Copies of Application, etc. to be Submitted Appendix 3　List of Prefectures/Regional Bureaus of Health and Welfare Appendix 4　Application Fees and Registration/License Taxes for Cellular and Tissue-based Products