OBJECTIVES: Access to medicines is usually given under the regulatory approvals and subsequent coverage decisions, after efficacy and safety have been proven by clinical trials. Recently, systems to enable exceptional early access have been explored to meet significant, unmet, and urgent medical needs for frontier medicines. In Japan, the Advanced Medical Care B system (AMCB) is already in operation. Two other systems, the Compassionate Use system (CU) and the Patient-Initiated Mixed-Care system (PIMC), are planned to start. The objective of this study is to understand the design and institutional positioning of these three systems, identifying opportunities for further improvements. METHODS: A documentary research was conducted by analyzing government documents and the Diet Record. RESULTS: For the AMCB system, the review board designates technologies that include the use of unapproved medicines or off-label indications, after requests from health care professionals. The CU system is to be fully introduced in 2015 and targets medicines at later stages of clinical development, opening up opportunities for patients who are not eligible for the trials. The PIMC system is to start in 2016 and focused on medicines or patients that are not covered by the other two systems. The three systems have no legal financial aid programs to cover the costs of experimental medicines, while the systems allow coverage of other treatment costs than those medicines. Details of the CU and PIMC systems are currently under discussion. CONCLUSIONS: The scopes of the three systems were found to be complementary to one another, covering both unapproved medicines and patients excluded from clinical studies. Legal financial aid would be worth considering for more equitable and extensive early access.