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