On May 8, 2015, Japan's Ministry of Health, Labor, and Welfare ("MHLW") commenced a pilot program to accelerate the development of certain pharmaceutical products whose applicants commit to conducting their initial product launches in Japan ("Sakigake Designation System"). Under the Sakigake Designation System, the MHLW may designate a drug for accelerated development if (i) the product is epoch-making, (ii) the product targets a serious disease, (iii) the product is significantly effective at treating the disease, and (iv) the applicant intends to develop the product and apply for product approval in Japan ahead of the rest of world. Such designation will provide preferential treatment for the new drug application, including a shortened review time from the typical 12 months to a period of six months. After the pilot, the MHLW will hold a hearing to consider extending the program.
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