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