TOKYO - Deregulation has thrust Japan to the forefront of a global battle for supremacy in regenerative medicine.
The government of Prime Minister Shinzo Abe made the nascent field a key part of its strategy for revitalizing the economy. A new law, as well as a major revision to the pharmaceutical affairs law, last fall made Japan arguably the world's most liberalized market for regenerative products and services.
This game-changing branch of medicine has the potential to fully heal organs and tissue damaged by diseases or accidents. It all starts with stem cells, which can grow into any type of cell. The new legislation, which took effect in November, opened the door for businesses other than hospitals and research institutes to produce cells for medical use.
The pharmaceutical law revision, also implemented in November, shortened the approval process for the cells. Now there is no need for a third stage of clinical trials to gain authorisation.
By retooling its drug framework, Japan has created "the world's fastest approval process specifically designed for regenerative medicine," the international scientific journal Nature said.
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