[Consideration of clinical development for new anticancer drugs on Japan, proposal from approval reviewer].
There become problems about a delay on clinical development of anticancer drug in Japan and drug lag. I consider causes and solutions of the problems from a position of drug approval reviewer. I think the drug lag may cause by stating later state in global clinical development or stagnation of clinical trial activities. To prevail against drug lag,it is necessary to attend to multinational clinical studies,and to mature Japanese clinical trial environment and post-market planning. Then, I believe that the most important point is to make a start on early stage of global clinical development.
Urano
Tsutomu
T
Office of New Drugs Evaluation I, Pharmaceuticals Medical Devices Agency.
D000970:Antineoplastic Agents; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D017723:Drug Utilization Review; D006801:Humans; D007564:Japan; D007880:Legislation, Drug; D008004:Licensure; D040541:Marketing; D013997:Time Factors
D000970:Antineoplastic Agents