Sakigake (さきがけ, lit. "pathfinder", "harbinger") is a drug designation by the

Pharmaceuticals and Medical Devices Agency The (PhMDA) is an Independent Administrative Institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan. It is similar in function to the Food and Drug Administration in the United Stat ...

, the pharmaceuticals regulator of Japan. It was designed to provide easier access to novel advanced treatments. It is analogous to the

Regenerative Medicine Advanced Therapy Regenerative Medicine Advanced Therapy (RMAT) is a designation given by the Food and Drug Administration to drug candidates intended to treat serious or life-threatening conditions under the 21st Century Cures Act. A RMAT designation allows for acc ...

designation in the

United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 U.S. state, states, a Washington, D.C., federal district, five ma ...

and the Advanced Therapy Medicinal Product designation in the

European Union The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been ...

History

The Sakigake designation was first announced as a pilot by the

Ministry of Health, Labour and Welfare The is a cabinet level ministry of the Japanese government. It is commonly known as in Japan. The ministry provides services on health, labour and welfare. It was formed with the merger of the former Ministry of Health and Welfare or and the ...

on 17 June 2014. The designation system is part of a wider strategy, also named Sakigake, to promote R&D and improve access to new pharmaceuticals. The Pharmaceutical & Medical Device Act Amendments of 2019, which entered into force on 1 September 2020, made the Sakigake designation system a permanent fixture. While application for the Sakigake designation was only open for a short period every year, the permanent Sakigake regime is open year-round.

Effect

The Sakigake designation opens up the possibility for sponsors to seek pre-application consultations, which provide clients with a fixed-price multi-track review of their application.

Statistics

, 24 drugs received Sakigake designation, but only 8 of these (33.33%) were approved.

References

Pharmaceuticals policy Regulation {{Pharma-stub