1。为什么突破性的研究结果与创新药物，医疗设备和再生医学产品无关？................................................................................. 1 1-1 Current status and issues .............................................................................................................................. 1 1-2 Elements necessary for practical application ................................................................................................ 2 1-3 Importance of regulatory science in promoting practical application ........................................................................................................................ 3 2。DEVELOPMENT FOR PRACTICAL USE ............................................................................................................... 3 2-1 Development process of drugs...................................................................................................................... 3 2-2 Development process of medical devices ..................................................................................................... 8 2-3 Development process for regenerative medical products ........................................................................... 10 3.DEALING WITH THE PHARMACEUTICAL AND MEDICAL DEVICE ACT (PMD ACT) NECESSARY FOR PRACTICAL APPLICATION ................................................................................................................................. 11 3-1 What is the Pharmaceutical and Medical Device Act?WHAT TO DO AT TIMES LIKE THIS (Q&A) ......................................................................................................... 30 7................................................................................. 11 3-2 Roles of Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) ........................................................................................................................................... 13 4.WHAT IS REGULATORY SCIENCE (RS) GENERAL CONSULTATION/REGULATORY SCIENCE (RS) STRATEGY CONSULTATION ............................................................................................................................... 14 4-1 Significance and purposes of RS general consultation/RS strategy consultation in the development process ........................................................................................................................................................ 14 1) Significance of RS general consultation/RS strategy consultation in development.................................... 14 2) Outline and purpose of RS general consultation/RS strategy consultation ................................................ 15 4-2 Consultation procedures …….............................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................咨询）.............................................................................................................................................................................................................................................................................................................................................................................................................................................................................................CONTACT INFORMATION ................................................................................................................................... 36 8.ACCESS ................................................................................................................................................................ 37 ANNEX LIST OF GUIDELINES .................................................................................................................................... 34