The effort to the issues of unapproved drugs and off-label use drugs has obtained a lot of results by the discussion of Review Conference on Unapproved or Off-label Use Drugs of High Therapeutic Needs and by the independent approach of pharmaceutical industries. However, not all those problems were solved. The fundamental solution of the issues of the drug lag closely related to unapproved drugs and off-label use drugs is a speedup of the new drug development and the review in Japan. Since the environment that surrounds pharmaceutical industries in Japan has changed considerably, new efforts such as the open innovation are needed. To improve the patient's access to drugs further, the Ministry of Health, Labour and Welfare tries to introduce the system of “Participation in the clinical trial from a humane viewpoint” and “Patient requested medical care system”. I describe the point that should be noted when those systems are designed and about the correspondence to off-label use drugs in the future.